Ide medical devices

Ide medical devices DEFAULT

FDA’s IDE: Data-Centric Approach to Med Device Innovation

2021-bl-investigational-device_715x320In July 2020, Switzerland-based medical device development company, Carag AG received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for its Carag Bioresorbable Septal Occluder (CBSO). The device is designed to help treat atrial septal defects (ASD). Earning the IDE gave Carag AG an opportunity to conduct a clinical trial with its device prior to submitting a premarket approval application (PMA). The study can provide valuable data regarding the device’s safety and effectiveness in treating patients with ASD.1

What is an FDA IDE Designation?

An investigational device exemption (IDE) is a regulatory option set up by the FDA that allows an investigational medical device to be used in a clinical study in order to collect safety and effectiveness data. This data is then used to support a PMA application as part of the 510(k) process.

Medical device companies may seek an IDE when clinical experience is necessary because nonclinical testing methods are either not available or not adequate to provide the data needed to develop the device. The IDE also applies to clinical evaluation of certain modifications or new intended uses of existing, legally marketed devices. All clinical evaluations of investigational devices must have an approved IDE before launching a study.2

Because the IDE is for investigational devices, the medical device developer works with an institutional review board (IRB) to initiate the application process. According to the FDA IDE guidance, the company and IRB need to determine if the device is considered a significant risk or nonsignificant risk prior to beginning the clinical study. However, the FDA has the ultimate authority to determine the level of risk. Significant risk means the device:

  • Can pose serious risk to the health, safety or welfare of a subject.
  • Is purported to sustain human life.
  • Is substantially important in treating disease or preventing impairment of human health.

Clinical Study Requirements

To conduct a clinical evaluation of an investigational medical device, the medical device developer must complete these IDE requirements outlined by the FDA:3

  • Complete the application process, which includes submitting an investigational plan for approval to the IRB.
  • Receive informed consent from all clinical subjects.
  • Label the device “for investigational use only.”
  • Monitor the study.
  • Produce the required records and reports from the study.

IDE Application

The IDE application must clearly state that the proposed study is an early feasibility study. Include the justification, using an appropriate benefit-risk analysis, for conducting this type of study. Addressing the following questions in the IDE application will help with achieving approval:

  • What clinical condition will the device treat or assess?
  • What is the standard of care for the clinical condition and expected outcomes associated with the standard?
  • What are the anticipated benefits of the study device?
  • Is the information included in the report of prior investigations adequate to support initiation of the study?
  • Does the investigational plan include a thorough risk analysis, sufficient risk mitigation strategies, adequate subject protection measures and an appropriate clinical study protocol?
  • Is initiation of the clinical study justified based on the clinical need for the device, and are the anticipated benefits likely to outweigh the potential risks?

Investigational Plan

Initiating an IDE application involves developing an investigational plan. This critical part of the IDE needs to be well thought out and comprehensive. It should identify the novelty of the device and the medical need as well as the limited nature of the investigation. In addition, the plan includes the following items:4

  • Description of the device and its intended use – The name of the device, its purpose and objectives of the clinical study.
  • Device study protocol – The methodology, including a description of the subjects, study endpoints, endpoint assessment methods and adverse event definitions.
  • Risk analysis and mitigation – A description and analysis of the type and estimated severity of risks to the subjects. Identify how the risks will be minimized and adequately justify that the risks are reasonable in relation to the expected benefits.
  • Monitoring processes – The FDA guidance on a risk-based approach to monitoring states that companies need to identify critical study data and processes. Then, identify the risks that could affect the collection of critical data or the performance of critical processes. The monitoring plan focuses on the important and likely risks to critical data and processes.
  • Additional records and reports – Include any additional data and information that support the need and benefits of conducting a clinical study.

The IRB uses the information in the investigational plan to determine if there is significant risk with the device and study. If the study is deemed to pose significant risk, the FDA must also review and approve the investigational plan.

Good Clinical Practices for IDE

During an investigational device clinical trial, medical device companies must comply with good clinical practices (GCP) specific to the IDE regulations detailed in 21 CFR 812:

  • 812:20 – Explains the requirements and process for submitting an IDE application, including the information the application must contain such as the investigational plan and report of prior investigations.
  • 812:25 – Lists the information that must be included in the investigational plan.
  • 812:27 – Specifies what information needs to be included in the report of prior investigations, i.e., all prior clinical, animal and laboratory testing of the device.
  • 812:35 – Applies to supplemental applications, which explains when changes to the device and investigational plan must have prior FDA approval as well as the protocol for notifying the FDA of changes that do not require prior approval.

Conducting an early feasibility study under an IDE provides a unique opportunity to obtain clinical experience with a new or modified device or new clinical use of an existing device. A study environment enables companies to use appropriate subject protection measures and GCP study practices. Data obtained from the study can provide valuable insight, which can be used to optimize device design, risk controls and quality processes.


References

  1. “Carag Receives U.S. FDA IDE Approval to Conduct Clinical Study of First Transcatheter Septal Occluder With Bioresorbable, Metal-free Framework,” Ken Dropiewski, CardiacVascularNews, July 2, 2020, http://cardiacvascularnews.com/carag-receives-u-s-fda-ide-approval-to-conduct-clinical-study-of-first-transcatheter-septal-occluder-with-bioresorbable-metal-free-framework/
  2. “Investigational Device Exemption (IDE),” U.S. Food and Drug Administration (FDA), Dec. 13, 2019, https://www.fda.gov/medical-devices/how-study-and-market-your-device/investigational-device-exemption-ide
  3. “Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration Staff,” U.S. Food and Drug Administration (FDA), Oct. 1, 2013, https://www.fda.gov/media/81784/download
  4. “Understanding FDA Regulatory Requirements for an Investigational Device Exemption (IDE) for Sponsor-Investigators,” M. E. Blair Holbein and Jelena Petrovic Berglund, U.S. National Library of Medicine National Institution of Health, National Center for Biotechnology Information, Oct. 2012, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3448842/

2019-bl-author-david-jensen

David Jensen is a content marketing specialist at MasterControl, where he is responsible for researching and writing content for web pages, white papers, brochures, emails, blog posts, presentation materials and social media. He has over 25 years of experience producing instructional, marketing and public relations content for various technology-related industries and audiences. Jensen writes extensively about cybersecurity, data integrity, cloud computing and medical device manufacturing. He has published articles in various industry publications such as Medical Product Outsourcing (MPO) and Bio Utah. Jensen holds a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.


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When it comes to FDA approvals there are several ways to obtain market release of a medical device in the U.S., such as the Premarket Approval, 510(k) or others. The investigational device exemption approval process may not always be the first one to think of, but it is important for all clinical investigations of devices.

 

How the process works

The IDE approval process is regulated in the 21 CFR 812 (Code of Federal Regulations). It denotes the submission process of an application to the FDA for significant risk device studies. However, there is also a process for obtaining IDE for non-significant risk device studies. The IDE is used to collect data on safety and performance of a medical device to support a PMA (Premarket Approval) or in some cases a 510(k) submission.

During the process, the sponsor and investigator are assigned certain responsibilities. A so-called investigator agreement needs to be drafted, which arranges device accountability, reporting and records, the review of the Institutional Review Board (IRB) and its informed consent. The Institutional Review Board plays an important role here and it is mainly looking for three essential aspects:

  • does the study involve a medical device at all,
  • is the medical device under evaluation intended for an IDE,
  • is the medical device a significant or nonsignificant risk device.

 

Significant risk device

The main characteristic of a significant risk device (SR device) is when the device poses potential serious risks to the health, safety, or welfare of a person. SR devices can be as well implants, that support or sustain human life, or devices that are essential in diagnosing, curing, mitigating or treating diseases or in another way preventing impairment to a person’s health. Examples of SR devices are: stents, respirators, dialysis machines, sutures, organ storage units, dental lasers for hard tissue or deep brain stimulators.

The process for SR devices contains the following steps (Note: studies for SR devices require both FDA and IRB approval before the study can be conducted):

  • The sponsor must submit a complete IDE application to the FDA
  • FDA reviews the application and approves or disapproves it
  • After FDA approval special requirements on the following aspects need to be fulfilled: labelling, distribution, informed consent, monitoring, prohibitions, record and reports

 

Nonsignificant risk device

A nonsignificant risk device (NSR device) does not pose a significant risk to persons or their health, safety, or welfare. For instance, such devices are most daily-wear contact lenses, caries removal solutions, gastroenterology and urology endoscopes and/or accessories or externally worn monitors for insulin reactions.

The FDA also provides a guidance document for the distinction between SR and NSR devices.

A NSR device study only requires IRB approval. The IDE process for this approval contains the following steps:

  • Sponsor presents the reviewing IRB a brief explanation why the device is not a significant risk device
  • IRB itself also determines whether the device is SR or NSR
  • If IRB agrees with the sponsor’s NSR determination the IRB can review and approve the study using the critical 21 CFR 56.111. Then the FDA considers the investigation of an NSR device to have an approved IDE
  • If the IRB disagrees with the NSR device determination, the sponsor must report this finding to the FDA
  • During the process the sponsor must fulfil aspects of the so-called abbreviated IDE requirements, such as labelling, IRB approval, informed consent, monitoring, records and reports, investigator records and reports, and prohibitions

 

When to apply?

An IDE is not needed when the study is …

  • routine practice of medicine. However, the physician should be well informed about the product, only use firm scientific rational and sound medical evidence and maintain records on use and effects.
  • a basic physiological research. Characteristics are the investigation of a physiological principle, no intent to develop the device for marketing, only using the device to address the research question – not safety and performance.
  • an exempt study (from 21 CFR 812). Description of exempt medical devices: approved devices used in accordance with labelling, most in vitro diagnostic devices, consumer preference testing, testing of a minor technical modification or testing of a combination of approved devices.

An IDE is needed when the study …

  • supports research or marketing applications. For a significant risk device research, the submission of an IDE application to FDA must follow all of 21 CFR 812. Non-significant risk device research requires IRB approval, after which the study is considered to have an IDE and needs to follow only 21 CFR 812.2(b).
  • is an investigation that collects data on safety and performance. Clinical investigations of devices where safety and performance data are collected will require IDE.
  • is designated to extend the intended use of the medical device. New intended use of an approved device may be different age population, new disease or condition, different body placement, changing from ‘treatment’ to ‘prevention’ for the same disease or new materials or design used in approved devices.

 

Good to know

In general, all clinical investigations of a device must have an approved IDE or be exempt from the IDE regulations. The FDA 21 CFR 812 provides information on scenarios where studies are exempted from the IDE. Further, it is a rule that the sponsor of the clinical trial is responsible for submission of the IDE application to the FDA. The sponsor or clinical investigator is also responsible for "prompt reporting to the IRB of changes in a research activity"; the completion of the study is for example a change in activity and should be reported to the IRB.

Also, it is the sponsor who obtains approval from the IRB before the study can begin. The FDA will notify the sponsor when the application is received. There are three possible reactions to the submission: approval, approval with modification and disapproval.

 

Summarised

When submitting an IDE, it is important to keep in mind that a significant risk device study requires FDA and IRB approval, whereas a non-significant risk device study requires IRB approval only. There is a crucial difference between the two procedures. The experts of the seleon gmbh are ready to help you with every step of the submission process.

 

Please note that all data and listings do not have the claim of completeness, are without guarantee and serve the pure information.

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IRB-HSR

Background

This guidance is intended to assist investigators in meeting the FDA requirements when investigating medical devices in clinical research and in some treatment situations. Federal regulation 21 CFR 812 defines the requirements for clinical investigations of medical devices.

All clinical investigations of devices must have an approved IDE (Investigational Device Exemption) from the FDA or be exempt from the IDE regulations before beginning a clinical investigational of a significant risk device. An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification 510(k) submission to FDA. 

First one must determine if something is a device according to the federal definitions. Per the statute: Federal Food, Drug, and Cosmetic Act Sec 201.h [21USC321]

DEVICE: The term "device" (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: 

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Per FDA Information Sheet Guidance for IRB's, Clinical Investigators, and Sponsors: Frequently Asked Questions About 

Who Must Apply for an IDE?

The sponsor of the clinical trial is responsible for submitting the IDE application to FDA (812.40) and obtaining Institutional Review Board (IRB) approval before the study can begin. Foreign companies wanting to conduct a clinical study in the U.S. MUST have a U.S. sponsor (812.18). Under certain circumstances, the clinical investigator may wish to submit an IDE and would, therefore, also act as the sponsor of the study. 

Federal law prohibits the distribution of medical devices until the FDA has reviewed clinical data and determined that a particular product is safe and effective for a specific use in human subjects. In order to test a new medical device in clinical trials, it is necessary to obtain an exemption from the FDA. Thus a device sponsor is required to apply for an Investigational Device Exemption (IDE) before tests with human subjects may begin. The investigator is responsible for obtaining the IDE number and providing it to the IRB. Studies that involve FDA-regulated products that are submitted without an IDE number will be reviewed by the IRB with respect to determining the need for an IDE, based on federal requirements and the investigator's response to questions contained in the protocol.

If the IRB determines that the study does not require an IDE and approves the study, the study may begin. If the IRB determines that an IDE is needed, the investigator/sponsor must submit an IDE application to the FDA and provide documentation of the outcome of the FDA determination (IDE number) to the IRB before the IRB gives approval to enroll subjects in the study.

When is an IDE from the FDA required?

  • Studies involving unapproved devices that are considered to be significant risk: An IDE from the FDA is required to perform clinical research using an unapproved device that poses a significant risk to subjects. Typically, these studies are conducted to collect safety and effectiveness data used to support Premarket Approval (PMA) applications submitted to the FDA.
  • Studies involving an approved device being tested for a new indication: IDE regulations also apply to significant risk studies testing an FDA-approved device for a new indication.

Example: Significant risk (SR) studies involve implantable devices such as cardiac pacemakers, orthopedic implants, and stents. SR studies can also involve products not introduced into the body, such as computer software used for prenatal risk evaluation. Each of these studies would require an IDE. For more information, see FDA guidance on Significant and Non-Significant Risk MedicalDevices.

Example: A legally marketed coronary stent would be considered an investigational device and would require an IDE if used as part of a study to collect safety and effectiveness data for treating occlusions of other vascular sites.

When is an IDE from the FDA not required?

  • Studies involving devices that are considered to be non-significant risk (NSR): An IDE from the FDA is not needed for research when the sponsor provides a brief explanation of why the device is NSR and the IRB agrees with the sponsor’s explanation.

The following guidance includes examples of significant-risk devices and NSR devices: Significant and Non-significant RiskMedical Devices.

Process for obtaining an IDE

  • Pre-IDE Process: Investigators considering submitting an IDE application to the FDA should communicate with the reviewing division of the Office of Device Evaluation (ODE) prior to the submission of an IDE application. See the FDA IDE Approval Process website for details.
  • The IDE Submission: The IDE submission to the FDA and the IRB application should be initiated at the same time. The FDA has 30 days to review the IDE application. Likewise, the IRB typically reviews an application within a 30-day window, but it may take longer to secure approval. Subjects may not be recruited or enrolled before FDA and IRB approval.

IDE Letter and Detailed Description of the Device

For all investigational devices, you must submit detailed information about the device, similar to an Investigator’s Brochure.

For research involving a significant risk device, investigators must submit an IDE approval letter from the FDA with the application for initial review. If the sponsor has not yet received the approval letter, the IRB will review the study and may approve it with the condition that the study cannot start until the investigator submits a copy of the IDE approval letter to the IRB and the IRB acknowledges receipt.

Ethical Considerations

For investigations involving a medical device that is exempt from the requirement for an IDE, the IRB may approve the study without an IDE.

For research that is not exempt from the requirement for an IDE, the IRB will determine if the investigational device is a significant risk device based on the information in the application.

  • If the IRB agrees that the device is NSR, an IDE from the FDA will not be required.
  • If the IRB determines that the device poses a significant risk, then the study will be reviewed at the Full Committee level for future submissions.

Investigator Responsibilities for Investigational Devices

If an investigator is the developer of the drug, biologic or medical device, and no commercial manufacturer is involved, then the investigator is also the sponsor for the purposes of designing and organizing clinical trials.

Sponsors also have important administrative and reporting requirements above and beyond those of investigators. Faculty contemplating the dual role of sponsor-investigator should consult with the School of Medicine Clinical Trials Office (SOM CTO) about the additional responsibilities that entails.

The sponsor must declare any individual financial conflict(s) of interests in the research and develop a management plan that is approved by the University.

Should an investigator associated with the University of Virginia or the University sponsor a multi-site study, that investigator is required to meet all the responsibilities of a sponsor as determined by DHHS guidance.

At the time of initial review, the IRB will require an approval from the SOM CTO who will assess the procedures for dissemination of protocol information (e.g. unanticipated problems involving risks to subjects or others, protocol modifications, interim findings) to all participating sites. In addition, the UVA PI must ensure that investigators at other research sites submit and follow requirements directed by their local IRBs.

IRB policies and procedures from each approving institution will be followed by researchers at that site. All required reports will be provided to the local IRB as per their policy. The coordinating PI at the University of Virginia will be responsible for providing local information as well as unanticipated problems involving risks to subjects or others, protocol modifications, or interim findings that may affect the control of investigational devices.

Control of Investigational Devices

Investigators conducting studies in which an investigational device will be used must ensure adequate control of the device. Adequate control and handling of investigational devices include all of the following:

  • Ensuring that the investigational device is used only as described in the IRB approved protocol, the signed agreement, the investigational plan and applicable FDA regulations.
  • Providing the investigational device only to participants under the investigator’s direct supervision or under the supervision of a sub-investigator responsible to the investigator.
  • Supplying the investigational device only to persons authorized to receive the device.
  • Maintaining accurate, complete, and current records relating to the investigator’s participation in an investigation, including records of receipt, use or disposition of a device that relate to:
    • The type and quantity of the device, dates of its receipt, and the batch number or code mark.
    • The names of all persons who received, used, or disposed of each device.
    • Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of.
  • Returning any unused devices or following the sponsor’s requirements for disposition of unused devices if the investigation is terminated, suspended, discontinued, or completed. See Sample Investigational Device Accountability Log.

Importing Medical Devices

A complete overview of medical device import/export regulations is provided by the Center for Devices and Radiological Health (CDRH). Clinical investigators should be aware that the FDA does not recognize regulatory approvals from other countries. Therefore, an imported medical device must meet all FDA requirements.

  • The IDE sponsor must be located in the United States.
  • Anyone who intends to import an investigational device takes on the responsibilities of a sponsor.

Investigator Reporting Requirements

Drug-Device Combination Products

If an investigator is interested in investigating a combination product, the following links may be useful:

  • The FDA’s Office of Combination Products (OCP) was created in 2002 to facilitate the review process for combination products by coordinating interactions between reviewing branches.
  • The OCP provides applicable guidance documents for combination products.
  • Some recent combination product approvals include:
    • Drug-eluting coronary stents;
    • Spinal fusion putty; and
    • An influenza vaccine administered via an intranasal delivery device.

Device Classifications

The level of regulatory controls placed on a medical device is determined by the risk classification. Most research reviewed by the IRB involves significant risk, Class III devices. To help determine device classification, regulatory controls, and exemptions, the CDRH maintains:

  • A searchable classification database containing information about all approved Class I, Class II, and Class III devices.
  • A listing of Class I and Class II devices deemed exempt from Premarket Notification 510(k) regulations.

Definitions

Medical device is defined, in part, as any health care product that does not achieve its primary intended purposes by chemical action or by being metabolized. Medical devices include, among other things, surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. Medical devices also include diagnostic aids such as reagents and test kits for in vitro diagnosis (IVD) of disease and other medical conditions such as pregnancy. A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:

  • recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes (21 U.S.C. 321(h)).

Investigational device means a device, including a transitional device, that is the object of an investigation. A medical device is considered investigational if either condition applies:

  • The device is not approved for marketing in the United States or
  • The device is approved for marketing but is being clinically evaluated for a new indication.

Investigational device exemption (IDE) IDE refers to the regulations under 21 CFR 812. An approved IDE means that the IRB (and FDA for significant risk devices) has approved the sponsor’s study application and all the requirements under 21 CFR 812 are met.

Significant riskdevice means an investigational device that:

(1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;

(2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;

(3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or

(4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

A Nonsignificant Risk (NSR) device study is one that does not meet the definition for a Significant Risk device study.

IDE Exempt means a study that is exempt from the requirements of regulations under 21 CFR 812. Two common investigations of medical devices that are exempt from the requirement for an IDE include:

  • Investigations conducted with legally marketed devices used according to labeling.
  • Studies using in vitro diagnostic devices labeled “for research purposes only” may be IDE-Exempt as per regulations if the testing:
    • Is noninvasive;
    • Does not require invasive sampling procedures that presents significant risk;
    • Does not introduce energy into a subject; and
    • Is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure

The IRB then will make an independent assessment of the risk of the investigational device to be used in the study. If the IRB agrees that the devices poses no significant risk to research subjects, the investigator will not be required to obtain an IDE from the FDA to conduct the study. If the IRB instead believes that the device poses significant risk to research subjects, the investigator will be notified by the IRB. The investigator in turn is required to notify the sponsor of the IRB's decision, and the sponsor must notify the FDA of the IRB determination regardless of whether the study is ultimately conducted at UVA. Investigational devices determined by the IRB to poses significant risk to research subjects, will be reviewed according to the requirements described below. 

Exemption for Devices

If something is determined to be a device, one must then determine if the device is exempt from FDA regulations. Devices that are exempted from 21 CFR 812 are described in §812.2(c) of the IDE regulation.  A summary of the FDA regulations for studies exempt from the IDE regulation include: 

* Noninvasive when applied to a diagnostic device or procedure, means one that DOES NOT by design or intention: 

According to 21CFR812.2(c) (7) a custom device as defined in 812.3(b) is exempt unless the device is being used to determine safety or effectiveness for commercial distribution.  A custom device means a device that:

Depending upon the nature of the investigation, those studies which are exempt from the requirements of the IDE regulation may or may not be exempt from the requirements for IRB review and approval under Part 56and the requirements for obtaining informed consent under Part 50. For guidance regarding the applicability of these regulations with respect to investigations being conducted under the provisions of §812.2(c), contact the IDE Staff at (301) 594-1190.

For a custom device, IRB approval is required as this would also not meet the definition of human subject research under 45CFR46. 

  1. a legally marketed device when used in accordance with its labeling 
  2. a diagnostic device if it complies with the labeling requirements in §809.10(c) and if the testing:
    • is noninvasive; *
    • does not require an invasive sampling procedure that presents significant risk; 
    • does not by design or intention introduce energy into a subject; and 
    • is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure; 
    • For a diagnostic device, IRB approval is required and no Investigational Device Exemption application must be made to the FDA. In addition, the IRB is not required to make any further determinations related to risk at the time of approval.
    • Penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra, or enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os.
    • Blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus samples of body fluids or tissues that are left over from samples taken for non-investigational purposes is also considered noninvasive.
  3. consumer preference testing, testing of a modification, or testing of a combination of devices if the device(s) are legally marketed device(s) [that is, the devices have an approved PMA, cleared Premarket Notification 510(k), or are exempt from 510(k)] AND if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk;
  4. a device intended solely for veterinary use; 
  5. a device shipped solely for research with laboratory animals and contains the labeling "CAUTION – Device for investigational use in laboratory animals or other tests that do not involve human subjects." 
  6. a custom device 
    • (1) Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist;
      (2) Is not generally available to, or generally used by, other physicians or dentists;
      (3) Is not generally available in finished form for purchase or for dispensing upon prescription;
      (4) Is not offered for commercial distribution through labeling or advertising; and
      (5) Is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.
  7. Computer programs may be medical devices - it depends on the specific program and exactly what it does. A determination for whether or not a product is a medical device can be obtained by submitting a 513(g) request for classification. More information can be found at http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm127147.htm
  8. Medical Mobile Apps: Mobile medical applications (apps) may be considered a device. See examples below. For additional information see the FDA Guidance on Mobile Medical Apps- 9-23 13

For more information see: Guidance on Electronic Storage of Highly Sensitive Data Policy

Examples of medical apps which are considered a device and thus regulated by the FDA:

Mobile apps that perform patient-specific analysis and provide patient-specific diagnosis, or treatment recommendations.

o apps that use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy;

o Computer Aided Detection software (CAD);

o image processing software24; and 

o radiation therapy treatment planning software 25.

Examples of medical apps which are NOT considered a device and thus are NOT regulated by the FDA:

Mobile apps that perform simple calculations routinely used in clinical practice - These are apps that are intended to provide a convenient way for clinicians to perform various simple medical calculations taught in medical schools and are routinely used in clinical practice. These apps are generally tailored for clinical use but retain functionality that is similar to simple general-purpose tools such as paper charts, spread sheets, timers or generic mathematical calculators. 

o Body Mass Index (BMI)

o Total Body Water / Urea Volume of Distribution

o Mean arterial pressure

o Glascow Coma Scale score

o APGAR score

o NIH Stroke Scale

o Delivery date estimator

Expanded Access to Unapproved Medical Devices

The Food and Drug Administration's Expanded Access Program allows for medical devices that are investigational (i.e., not FDA approved) to be used for treatment use outside of a clinical trial. Such use is not considered a clinical investigation however, FDA submission AND IRB review are necessary. 

The criteria for Expanded Access are largely determined by (1) the seriousness of a patient's condition, (2) other available FDA-approved treatment options, (3) patient population size needing treatment, and (4) device status.

Unapproved medical device: is a device that is utilized for a purpose, condition, or use for which the device requires, but does not have, an approved application for premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e)(the act) or an approved IDE under section 520(g) of the act (21 U.S.C. 360j(g)).

IDE: An approved investigational device exemption permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device.

If enrollment in an existing clinical trial is not possible (e.g., a patient is not eligible for any ongoing clinical trials, or there are no ongoing clinical trials to address the patient’s condition), patients/physicians have the potential to receive expanded access to investigational devices under one of three alternative mechanisms.

Single Patient Emergency Use of an Unapproved Medical Device:

Note:  DO NOT USE CRCONNECT or Protocol Builder to create your templates.

The FDA defines "emergency use" as the use of a test article when:

  1. The patient has a life-threatening condition that needs IMMEDIATE treatment
  2. No generally acceptable alternative treatment for the condition exists; and
  3. Because of the immediate need to use the medical device, there is no time to use existing procedures to obtain FDA approval for the use obtain IRB approval [21 CFR 56or.102 (d)] [PDF].

Emergency use of an unapproved device may also occur when:

  1. An IDE for the device does not exist, or
  2. When a physician wants to use the device in a way not approved under the IDE, or
  3. When a physician is not an investigator under the IDE 

Life-threatening, for the purposes of section 56.102(d), includes the scope of both life-threatening and severely debilitating, as defined below.

  • Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the patients must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.
  • Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.

FDA expects the physician to make the determination that the patient’s circumstances meet the above criteria (1-3), to assess the potential for benefit from the use of the unapproved medical device and to have substantial reason to believe that benefits will exist.

If there is an IDE for the unapproved medical device, the IDE sponsor must notify the FDA of the emergency use within 5 days through submission of an IDE Report (§812.35(a)(2)).This follow-up report should include a summary of the conditions constituting the emergency, the patient protection measures that were followed, and patient outcome information.

If no IDE exists, the UVA physician should submit a follow-up report on the use of the device (description of device used, details of the case, and the patient protection measures that were followed) to:

Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Ave Document Control Center WO66 Rm G-609 Silver Spring, MD 20993

Procedures for IRB submission for Single Patient Emergency use of an Unapproved Medical Device

Emergency Use does not need IRB or FDA approval before use. However, if there is time, the UVA IRB-HSR asks that, the IRB-HSR be notified in advance of the proposed emergency use of an unapproved medical device.  

FDA guidance indicates that BEFORE using an unapproved medical device, the physician should take as many of the following patient protection measures as possible, and provide the following information in the submission:

  • Obtain a written independent assessment of the use of the device by an uninvolved, independent physician
  • Obtain documented informed consent from the patient or patient’s legally authorized using the template: Emergency Use or Expanded Access Consent for Investigational Drugs, Biologics or Device
    • If consent cannot be obtained before use, please let the IRB-HSR know why this was the case in your correspondence. The UVA physician and an independent licensed physician who is not participating in the medical care of the patient must certify in writing that:
      • The patient has a life-threatening or serious disease or condition
      • There was an inability to communicate with or obtain legally effective informed consent from the patient
      • There was not sufficient time to obtain informed consent from the subject or legally authorized representative
      • There was no available alternative method of FDA-approved or generally recognized therapy that provided an equal or greater likelihood of saving the patient’s life.
  • Obtain documented authorization from the holder of the IDE/device manufacturer
  • Obtain clearance from UVA Clinical Engineering for use of the unapproved investigational medical device
  • Notify the UVA IRB with a written description of the circumstances necessitating the use of the device, along with documentation of the uninvolved physician’s assessment, informed consent, and the IDE holder’s authorization.

NOTE: In the event of a waiver of informed consent for an emergency use, the IRB Chair or Designated IRB member, will confirm that both the investigator and an independent physician who is not otherwise participating in the care of the patient, have certified in writing all of the following:

  • the patient is confronted by a life-threatening situation necessitating use of the test article;
  • informed consent cannot be obtained because of an inability to communicate with, or obtain legally effective consent from, the patient;
  • time is insufficient to obtain consent from the patient’s legally authorized representative;
  • no alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the patient’s life;

Prior FDA approval for shipment or use of the device is not necessary but emergency use needs to be reported to the FDA and IRB. The information to the FDA should be submitted by the sponsor (IDE holder). If the unapproved medical device is not under an IDE, the investigator should submit the information directly to the FDA.

Send the following documentation to the UVA IRB via [email protected]Subject: Request for Single Patient Treatment Use of an Unapproved Medical Device 

Emergency use to the UVA IRB-HSR and the FDA must be reported within five working days.

Include the following documentation:

SINGLE PATIENT NON-EMERGNECY USE

Note:  DO NOT USE CRCONNECT or Protocol Builder to create your templates.

FDA approval and IRB Concurrence are required BEFORE the use of the device. The submissions to the FDA and the IRB -HSR can occur simultaneously, but both are needed before use.

FDA guidance indicates that BEFORE using an unapproved medical device, the physician should take as many of the following patient protection measures as possible, and provide the following information in the submission:

  • Obtain a written independent assessment of the use of the device by an uninvolved, independent physician
  • Obtain documented informed consent from the patient or patient’s legally authorized using the template:  Emergency Use or Expanded Access Consent for Investigational Drugs, Biologics or Device
    • If consent cannot be obtained before use, please let the IRB-HSR know why this was the case in your correspondence. The UVA physician and an independent licensed physician who is not participating in the medical care of the patient must certify in writing that:
      • The patient has a life-threatening or serious disease or condition
      • There was an inability to communicate with or obtain legally effective informed consent from the patient
      • There was not sufficient time to obtain informed consent from the subject or legally authorized representative
      • There was no available alternative method of FDA-approved or generally recognized therapy that provided an equal or greater likelihood of saving the patient’s life.
  • Obtain documented authorization from the holder of the IDE/device manufacturer
  • Obtain clearance from Clinical Engineering for use of the unapproved investigational medical device

Notify the UVA IRB with a written description of the circumstances necessitating the use of the device, along with documentation of the uninvolved physician’s assessment, informed consent, and the IDE holder’s authorization.

The physician who intends to use the device must determine that the following criteria are met:

  • The medical device is intended to treat or diagnose a serious disease or condition
  • There is no comparable or satisfactory alternative device or therapy available

Procedures for IRB submission for Single Patient Non-Emergency Treatment use of an Investigational Medical Device

Send the following documentation to the UVA IRB via [email protected]Subject: Request for Single Patient Non-Emergency Treatment Use of an Unapproved Medical Device 

The sponsor of the IDE/device manufacturer is required to submit an IDE supplement requesting approval under 812.35(a) in order to treat the patient.  For further instructions about FDA requirements for the IDE supplement, please refer to the FDA website.

The physician may not treat the patient identified in the IDE supplement until FDA approves the treatment use for the intended patient.  FDA will consider preliminary evidence of safety and effectiveness as well as whether the compassionate use would interview with the conduct of a clinical trial to support marketing approval.  Once approved, the patient should be monitored for safety.   Follow up information on the use of the device should be submitted in an IDE Report after compassionate use has ended.

FOLLOW-UP:

After the use of the test article, you are required to notify the UVA IRB-HSR within 5 working days about the status of the patient using the Single Patient Treatment Follow-up form.  The FDA and sponsor will need a similar report. Be aware of the reporting requirements noted in the table that follows.

TREATMENT USE FOR UNAPPROVED MEDICAL DEVICES (intermediate or large groups)

These procedures are intended to facilitate that availability of devices that are not FDA approved for marketing but are under clinical investigation for a serious or immediately life-threatening disease or condition in patients for whom there is no comparable or satisfactory alternative device or treatment available.  During the trial or prior to final FDA action on the marketing approval, it may be appropriate to use the device to treat patients not in the trial under treatment IDE regulations (21 CFR 812.36).
For the purposes of treatment use, immediately life-threatening disease means a stage of a disease in which there is reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.

The physician who intends to use the device must determine that the following criteria are met:

  • The device is intended to treat or diagnose a serious or immediately life-threatening disease or condition;
  • There is no comparable or satisfactory alternative device or other therapy available to treat or diagnose that stage of the disease or condition in the intended patient population;
  • The device is under investigation in a controlled clinical trial for the same use under an approved IDE, or such clinical trials have been completed; and
  • The sponsor of the investigation is actively pursuing marketing approval/clearance of the investigational device with due diligence.
Procedures for IRB submission of protocols for treatment use of unapproved devices
For investigator-initiated IDEs, compassionate use protocols must be submitted per usual procedures through CRCONNECT and the UVA IRB-HSR and requires full IRB review and approval under FDA regulations.  Please see the School of Medicine website for information about preparing an IDE submission to FDA.

CONTINUED ACCESS (EXTENDED INVESTIGATION) OF AN UNAPPROVED MEDICAL DEVICE

FDA may allow continued enrollment of subjects after the clinical trial under an IDE has been completed to allow access to the investigational medical device while the marketing application is being prepared by the sponsor or reviewed by FDA.  This is known as an “extended investigation”. A sponsor’s request for an extended investigation should be submitted as an IDE supplement. 

The physician who intends to use the device must determine that the following criteria are met:

  • Public health need for the device, OR
  • Preliminary evidence that the device will be effective and there are no significant safety concerns
Procedures for IRB submission of protocols for continued access to unapproved devices

For investigator-initiated IDE supplements for an extended investigation, continued access protocols must be submitted per usual procedures through CRCONNECT and the UVA IRB-HSR and requires full IRB review and approval under FDA regulations.  Please see the School of Medicine website for information about preparing an IDE submission to FDA.

HUMANITARIAN USE DEVICE

A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.  FDA regulations (21 CFR 814.124) provide for the submission of a Humanitarian Device Exemption (HDE) in which the manufacturer is not required to provide the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose prior to marketing. This regulation was developed to provide an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations.

An HDE is a type of Pre-Market Approval (PMA) that allows the FDA to grant an exemption from the effectiveness requirements of the PMA regulations. Devices approved with an HDE are referred to as a Humanitarian Use Devices (HUD). The provisions for obtaining an HDE are:

  • The device is designed to treat or diagnose a disease or condition that affects fewer than 8,000 individuals per year in the U.S.
  • The device is not available otherwise, and there is no comparable device available to treat or diagnose the disease or condition; and
  • The device will not expose patients to unreasonable or significant risk, and the benefits to health from the use outweigh the risks.

Treatment under an HDE is not considered research, but the FDA requires IRB approval prior to use. The IRB looks at the safety of the device and decides what information patients should receive about the safety and effectiveness of the HUD. Physicians who want to use a HUD at UVA should submit a standard IRB application through CRCONNECT and Protocol builder.

When the manufacturer submits the HDE it must provide sufficient information in order for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury to the patient and that the probable benefits to health outweigh the risk of injury or illness from its use.

A Humanitarian Device Exemption (HDE) application is similar to a premarket approval (PMA) application. However, due to the limited size of the target population and the impracticability of conducting clincal trials to establish safety and effectiveness, an HDE is exempt from the requirement to establish reasonable assurance of effectiveness. The FDA's approval is based its determination that the device will not expose patients to an unreasonable risk of injury or illness and the "probable benefit" to health. This is a considerably lower standard than proof of safety and effectiveness.

FDA approval of an HDE authorizes an applicant to market the HUD, subject to certain profit and use restrictions. HUDs cannot be sold for profit, except in very limited circumstances. Most importantly, they can only be used in a facility after an IRB has approved their use in that facility, except in certain emergencies.

How is an HDE different from an IDE?

An IDE is an exemption that allows a sponsor to ship an investigational device prior to marketing approval; it authorizes the investigational use of the device. A HUD with an approved HDE is approved for marketing. This means that the sponsor can ship the device and can bill for its use (but cannot make a profit from its sale except under limited circumstances). To receive approval for an HDE, the FDA must conclude that there is no comparable device available to treat the disease or condition. If a comparable device is approved by the FDA, the HDE approval may be withdrawn. An HDE therefore is analogous to a PMA application; it’s an application to market the device. An IDE is an application to ship an investigational device to conduct studies.

To approve a PMA device, the sponsor has to provide data from adequate and well-controlled trials that provide substantial evidence of effectiveness (and safety). The requirements for approval of an HDE application to market a HUD are quite a bit lower. FDA's Q&A states that an approved HDE represents "a determination by FDA that the HUD will not expose patients to an unreasonable or significant risk of illness or injury and the probable benefit to health from use of the device outweighs the risk of injury or illness from its use while taking into account the probable risks and benefits of currently available devices or alternative forms of treatment."

What are the IRB's Responsibilities for a HUD?

Before a HUD under an approved HDE can be used at the University of Utah or its affiliates for clinical care, approval by an IRB is required, with the exception of emergency use. A HUD is the only situation where federal regulations require the IRB to approve and monitor an activity that is clearly not research. The IRB review of HUDs can be particularly challenging, given that there is no research objective or design, no investigational device, no subjects, no study harm, or benefits. The primary reason for this requirement may be to give notice to the institution that the HUD will be used. It should be noted that the IRB’s approval for the use of a HUD at a facility to treat or diagnose patients in the course of providing clinical care does not mean that there is IRB approval of a clinical investigation involving the HUD.

After HDE approval, a HUD may only be used after IRB-HSR Full Board approval has been obtained for the use of the device, even for the FDA-approved indication, except for an emergency use situation. The IRB is required to perform its initial review at a convened meeting using the criteria for approval at 21 CFR 56.111. Subsequent continuing reviews - at least annually - may be performed using expedited procedures. Expedited review is permitted because a HUD is an approved device.

The IRB may approve the device for either

  • General use; or
  • For groups of HUD patients that meet certain criteria;.
  • For patients under a HUD protocol; or
  • On a case-by-case basis.

Physician Responsibilities for the Use of a HUD

Note:  DO NOT USE CRCONNECT or Protocol Builder to create your templates.

A physician may utilize a HUD when agreeing to the following:

  • The HUD will be utilized for treatment, diagnosis, or research in accordance with the labeling of the device, intended purpose, and in the designated population for which the FDA approved its use;
  • The patient must be informed that the HUD is a device authorized under Federal law for use; however, the effectiveness of the device for a specific indication has not been demonstrated; and
  • The informed consent of the patient or the patient’s legally authorized representative will be obtained when the use of the HUD involves research or when required by the IRB. The IRB generally requires that treating physicians obtain informed consent. A HUD Informed Consent form template has been developed for your use.

IRB Submission Requirements for Use of a HUD

Regardless of the intended use, a HUD requires prospective IRB review and approval by the full board, with the exception of Emergency Use of an HDE. For an Emergency HDE, refer to process outlined earlier for ”Single Patient Emergency Use of an Unapproved Medical Device”:

Send the following documentation to the UVA IRB via [email protected]Subject: HUD Request

Continuing Review Requirements for HUD

The physician is responsible for fulfilling continuing review requirements to the IRB at least annually. At the time of continuing review, the physician must report the HUD activities for the previous 6 months from UVA. In addition, the following information must be provided to the IRB in summary form for each HUD at UVA. This report must include the following:

  • The clinical indications for the use of the HUD in each patient;
  • Clinical outcomes of each participant, if known.

Modifications to the HUD

Modifications to the HUD or the clinical use of the HUD are to be promptly reported to the UVA IRB in accordance with the IRB policy for Modifications at UVA.

Emergency Use of a HUD

Off-label use of a HUD in an emergency situation that cannot wait for IRB review and approval may be handled under Single Patient Emergency Use of an Unapproved Medical Device provision provided that the situation meets the FDA criteria under 21 CFR 56.104 (d) and the HUD is not used outside its approved labeling.

Required Approval Process to Use a New Device at UVA Health System

No medical device (supplies, accessories, or equipment), whether purchased, contracted, donated, loaned or for trial, may be used in the Medical Center for inpatient or outpatient care purposes without first being evaluated by Clinical Engineering. 

The Food and Drug Administration (FDA) defines a medical device as any instrument, apparatus, or other article that is used to prevent, diagnose, mitigate, or treat a disease or to affect the structure or function of the body, with the exception of drugs. This means that the FDA classifies common hospital products such as catheters, thermometers, patient restraints and syringes as medical devices.

In order to obtain approval submit the New Medical Device Request Form online at https://www.healthsystem.virginia.edu/newmedicaldevice/index.cfm?requestid=new

Resources

Sours: https://research.virginia.edu/irb-hsr/investigational-medical-devices
41 Basic Hospital Equipments With Names And Their Uses

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

Clinical evaluation of devices that have not been cleared for marketing requires:

  • an investigational plan approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by FDA;
  • informed consent from all patients;
  • labeling stating that the device is for investigational use only;
  • monitoring of the study and;
  • required records and reports.

An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (FD&C Act) that would apply to devices in commercial distribution. Sponsors need not submit a PMA or Premarket Notification 510(k), register their establishment, or list the device while the device is under investigation. Sponsors of IDE's are also exempt from the Quality System (QS) Regulation except for the requirements for design controls (21 CFR 820.30).

Good Clinical Practices (GCP)

Good Clinical Practices (GCP) refers to the regulations and requirements that must be complied with while conducting a clinical study. These regulations apply to the manufacturers, sponsors, clinical investigators, institutional review boards, and the medical device. The primary regulations that govern the conduct of clinical studies are included in the Code of Federal Regulations, Title 21 (21 CFR):

  • 21 CFR 812, Investigational Device Exemptions, covers the procedures for the conduct of clinical studies with medical devices including application, responsibilities of sponsors and investigators, labeling, records, and reports.
  • 21 CFR 50, Protection of Human Subjects, provides the requirements and general elements of informed consent;
  • 21 CFR 56, Institutional Review Boards, covers the procedures and responsibilities for institutional review boards (IRBs) that approve clinical investigations protocols;
  • 21 CFR 54, Financial Disclosure by Clinical Investigators, covers the disclosure of financial compensation to clinical investigators which is part of FDA’s assessment of the reliability of the clinical data.
  • 21 CFR 820 Subpart C, Design Controls of the Quality System Regulation, provides the requirement for procedures to control the design of the device in order to ensure that the specified design requirements are met.

Each of these regulations is discussed in detail throughout this section.


Additional Information



  • Content current as of:

  • Regulated Product(s)

    Topic(s)

Sours: https://www.fda.gov/medical-devices/how-study-and-market-your-device/investigational-device-exemption-ide

Medical devices ide

Adverse Events

If my device has been approved and marketed in a foreign country and I am conducting clinical trials in the U.S., should I report an adverse event from the U.S. trial under the IDE program or the Medical Device Reporting (MDR) program?

If your device is not marketed in the U.S., you should report an adverse event under the IDE program (812.150). The sponsor must report the results of an evaluation of an unanticipated adverse device effect to FDA and all reviewing IRBs and investigators within 10 working days after the sponsor first receives notice of the adverse effect.

If the adverse event occurs in a foreign country in which it is legally marketed and not under the control of a clinical study, the adverse event should be discussed in the IDE progress report since the adverse information may affect risk analysis.

The adverse event should not be reported under the MDR program because the MDR program only applies to medical devices that are legally marketed in the U.S.

My device is marketed in the U.S. I am conducting a clinical trial in the U.S. for the same device, but for a different indication for use, should I report an adverse event under the IDE program or the MDR program?

Adverse events that occur in subjects enrolled in the clinical trial should be reported under the IDE program (812.150). The sponsor must report the results of an evaluation of an unanticipated adverse device effect to FDA and all reviewing IRBs and investigators within 10 working days after the sponsor first receives notice of the adverse effect.

Adverse events that occur in the U.S. but outside of the clinical trial would be reported through MDR; however, the adverse event should be discussed in the IDE progress report since the adverse information may affect risk analysis.

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Clinical Investigator

Can a clinical investigator submit an IDE?

Yes, a clinical investigator can sponsor his/her own study in which case they are considered a sponsor-investigator and must comply with all the responsibilities of both the sponsor and investigator.

Does the clinical investigator need to sign form FDA-1572?

No, this is a form used for drug studies. For device studies, the sponsor should develop an investigators agreement which includes the elements of 21 CFR 812.43(c). The sponsor should have all investigators sign the agreement prior to participating in the study.

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Confidentiality

Are IDE records released to the public?

FDA will not disclose the existence of an IDE unless:

  • FDA determines that the information had been previously disclosed to the public;
  • FDA approves a PMA for a device subject to an IDE; or
  • a notice of completion of a Product Development Protocol (PDP) is in effect.

If the existence of an IDE file has not been publicly disclosed or acknowledged, no data or information in the file are available for public disclosure except for information on banned devices and a report of an adverse effect to an individual on whom an investigational device has been used. [(§812.38)]

Data or information contained in the file is not available for public disclosure before approval of an application for PMA or the effective date of a notice of completion of a PDP. Upon approval FDA will release a summary of the safety and effectiveness data on which the decision was based. Other disclosable information available after the device has been approved includes any protocol for a test or study, adverse reaction reports, and correspondence after confidential information has been deleted. Information available for public disclosure is outlined in 21 CFR 814 Premarket Approval of Medical Devices section §814.9.

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Early Collaboration

Can I receive advice from FDA on non-clinical testing and/or on my clinical protocol?

Yes. There are numerous guidance documents available from FDA that provide recommendations on the non-clinical and clinical testing of specific device types. Additionally, FDA accepts Pre-Submissions, in which you can submit information to FDA and receive advice on topics such as a non-clinical testing plan and/or a draft clinical protocol. Additional information on Pre-Submissions may be found in the FDA guidance "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program." FDA's guidance represents FDA’s approach to this topic.

Additionally, there are two types of early collaboration meetings available that are discussed in the FDA guidance "Early Collaboration Meetings Under the FDA Modernization Act (FDAMA)". These formal interactions (Determination Meetings and Agreement Meetings) are specific to clinical investigations and do not address non-clinical testing or protocols.

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FDA Contacts

I have questions about the IDE regulations. Who should I contact at CDRH?

For comprehensive regulatory education about medical devices and radiation-emitting products, please see Device Advice and CDRH Learn. Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website for more information or contact DICE by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

For questions about devices regulated by the Center for Biologics Evaluation and Research (CBER), contact CBER’s Office of Communication, Outreach and Development (OCOD) at either 1-800-835-4709 or [email protected]

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Foreign companies/studies

Can a foreign company submit an IDE/Is a U.S. Sponsor required?

A foreign company cannot sponsor an IDE; the company must have a U.S. agent who acts as the sponsor (see 21 CFR 812.18(a)). The U.S. agent must fulfill all the responsibilities of a sponsor identified in the IDE regulations.

Do clinical studies have to be conducted in the U.S. / Will foreign studies be accepted?

The FDA continues to promote global harmonization in many aspects of medical device development and regulation, including our commitment to recognize the value of and accept, where appropriate, data from multiple sources and countries.

For more information regarding the FDA’s acceptance of clinical data refer to our page on Acceptance of Data from Clinical Investigations for Medical Devices and the FDA guidance entitled “FDA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions.”.

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In Vitro Diagnostic devices

Do the IDE regulations apply to in vitro diagnostic devices?

Many in vitro diagnostic (IVD) devices are exempt from the IDE regulations. Under section §812.2(c) of the IDE regulations, studies exempt from the IDE regulations include diagnostic devices if the testing:

  • is noninvasive;
  • does not require an invasive sampling procedure that presents significant risk;
  • does not by design or intention introduce energy into a subject; and
  • is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure;

IVD devices that are under study, including IVD devices that are exempt from the IDE regulations, must comply with labeling requirements under 21 CFR 809.10(c)(2). One of two statements is required, as applicable for each case: "For Research Use Only. Not for use in diagnostic procedures", or "For Investigational Use Only. The performance characteristics of this product have not been established."

Studies which are exempt from the requirements of the IDE regulations are not exempt from the requirements for IRB review and approval under Part 56 and the requirements for obtaining informed consent under Part 50. In addition, IDE exempt studies are not exempt from §812.119, Disqualification of a clinical investigator.

For guidance regarding the applicability of these regulations with respect to investigations being conducted under the provisions of §812.2(c), contact the reviewing IRB and/or the CDRH IDE Staff at 301-796-5640 or CBER’s OCOD at 301-827-1800 .

Additional guidance for in vitro diagnostic device studies can be found in the guidance “In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions.”

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Institutional Review Board (IRB)

Where can I find an IRB?

The institutions where the study is to be conducted should be contacted to determine if they have their own IRB. If the study is conducted at a site that does not have its own IRB, the investigators should be queried to see if they are affiliated with an institution with an IRB that would be willing to act as the IRB for that site in the study. There are also independent/contract IRBs that can be contracted to act as the IRB for a site. Additionally, an IRB reviewing and approving IDE investigations should comply with the requirement of 21 CFR Part 56. Additional information on IRBs is available in the FDA Information Sheets.

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Labeling

Are there special labeling requirements for investigational devices?

Yes. Under § 812.5 an investigational device or its immediate package must bear a label with the following information:

  • the name and place of business of the manufacturer, packer, or distributor;
  • the quantity of contents, if appropriate; and
  • the statement, "CAUTION ­­ Investigational device. Limited by Federal (or United States) law to investigational use."

The label must also describe all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions.

The labeling of an investigational device must not contain any false or misleading statements nor imply that the device is safe or effective for the purposes being investigated.

If the investigational device is used solely for research on laboratory animals, the label must contain the following statement: "CAUTION ­­ Device for investigational use in laboratory animals or other tests that do not involve human subjects."

The sponsor should provide detailed information on device labeling in the investigational plan. This information may vary depending on the device and the nature of the study. Product labeling should be sufficient to ensure stability of the test article for the duration of the study (storage requirements, calibration procedures), bear sufficient directions for proper administration, and detail procedures to follow in the event of patient injury.

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New Indication for Marketed Device

Do IDE regulations apply if the device has already been approved for a different indication for use?

Yes, the clinical study of a new indication for an already marketed device falls under the IDE regulations.

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Promotion of Investigational Devices

Can I advertise my investigational device? What other restrictions apply?

Under § 812.7, a sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator cannot:

  • Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.
  • Commercialize an investigational device by charging the subjects or investigators a higher price than that necessary to recover costs of manufacture, research, development, and handling.
  • Unduly prolong an investigation. If data developed by the investigation indicate that premarket approval (PMA) cannot be justified, the sponsor must promptly terminate the investigation.
  • Represent that an investigational device is safe or effective.

However, the sponsor may advertise for research subjects to solicit their participation in a study. Appropriate advertising methods include but are not necessarily limited to: newspaper, radio, TV, bulletin boards, posters, and flyers that are intended for prospective subjects.

Advertisements should be reviewed and approved by the IRB to assure that they are not unduly coercive and do not promise a certainty of cure beyond what is outlined in the consent and the protocol. No claims should be made, either explicitly or implicitly, that the device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other device.

FDA considers direct advertising for study subjects to be the start of the informed consent and subject selection processes.

Additional guidance is available in the following guidance documents:

"IRB Information Sheets - Recruiting for Study Subjects".

Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects

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Medicare Coverage

Will insurance cover treatment with an investigational device?

For patients with Medicare, the Centers for Medicare and Medicaid Services (CMS) determines whether costs associated with routine care and the investigational devices are covered. To support this determination, the FDA categorizes IDE-approved devices based on whether available data demonstrates that initial questions of safety and effectiveness have been resolved. IDE-approved devices are assigned to one of two categories:

  • Category A - Experimental
  • Category B - Non Experimental/Investigational

The FDA communicates the assigned category in a formal letter sent to the study sponsor. The sponsor submits the letter to CMS, which considers the FDA-assigned category and other factors to determine whether or not a device meets the requirements for Medicare coverage. The background and criteria associated with the FDA’s categorization process is described in the guidance document titled, “FDA Categorization of IDE Devices to Assist CMS with Coverage Decisions.”

For an IDE-approved device assigned to Category A, CMS may cover only routine care items and services, but not the cost of the device itself. For an IDE-approved device assigned to Category B, CMS may cover routine care items and services as well as the cost of the investigational device if specific criteria are met. If the criteria are not met for a Category B device, neither the device nor other elements of the study are covered by Medicare. To review the criteria and process for requesting coverage for an IDE, the IDE sponsor may refer to their website (Medicare Coverage Related to Investigational Device Exemption (IDE) Studies).

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Significant/Nonsignificant Risk

Is my study significant risk or nonsignificant risk?

FDA has a guidance document to help explain how to determine whether a device study is significant or nonsignificant risk. If the sponsor believes a device study is nonsignificant risk, the sponsor can provide information to the IRBs reviewing the study explaining why the device study does not pose a significant risk. If the IRBs agree and approve the study, the research may be conducted and FDA does not need to be notified. However, if an IRB determines the study is significant risk, the sponsor must notify FDA in writing (21 CFR 812.150(b)(9)). The study may not begin until FDA approves the study or provides a determination that the investigation is nonsignificant risk.

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Statistical Guidance

How many subjects and sites do I have to include in the study?

The number of subjects and sites to include in a study depends on the study objectives and the study design needed to result in a scientifically valid conclusion.

It is recommended that more than one site be included to provide assurance that study results are reproducible.

FDA has developed several guidance documents that address statistics for clinical trials.

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Study sites

I am a patient. Where can I find a clinical study that will help me?

There is no centralized repository for information on device clinical trials. Your health care provider may be able to provide information. Hospitals associated with medical schools are often involved in research and institutions that are participating in clinical trials will sometimes place advertisements in newspapers or magazines to recruit subjects.

At this time, FDA does not maintain a clinical trials database for medical devices and our regulations do not permit us to release information regarding investigational devices. However, the National Institutes of Health maintains a clinical trials database for trials that they support. It may be accessed through the Internet at ClinicalTrials.gov. Please remember that participating in a clinical trial may or may not help you. The safety and effectiveness of an investigational device is not known.

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Waivers

Can the sponsor get a waiver from certain IDE requirements?

Under § 812.10, a sponsor may request FDA to waive any requirement of the IDE regulations. A waiver request with supporting documentation may be submitted as part of an application or separately. FDA may grant a waiver of any requirement that is not required by the FD&C Act and that is unnecessary to protect the human subject by providing a letter to the sponsor outlining the waiver.

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  • Content current as of:

Sours: https://www.fda.gov/medical-devices/investigational-device-exemption-ide/faqs-about-investigational-device-exemption
FDA Regulation of Medical Devices (Part 1 of 3)

Investigational Medical Devices

April 2016

  1. What is a medical device?
  2. What is an investigational medical device?
  3. How are investigational medical devices classified?
  4. What is the Difference between Significant and Non-Significant Risk Devices?
  5. Does the FDA Have Ultimate Authority to Determine SR/NSR Classification?
  6. What is an Investigational Device Exemption (IDE)?
  7. What is “Compassionate Treatment Use” of a Device under an IDE?
  8. Are there investigational medical devices that are exempt from FDA IDE regulations?
  9. When must a Sponsor/Investigator apply for an IDE?
  10. What other Medical Device Studies may be conducted without an IDE?
  11. Do IDE regulations apply if the device has already been approved for a different use?
  12. IRB review of device studies
  13. Does Medicare cover investigational medical devices and related services?

1. What is a medical device?

The FDA regulations define items that are considered medical devices.  A medical device is defined, in part, as any health care product that does not achieve its primary intended purposes by chemical action or by being metabolized.  Medical devices include, among other things, surgical laser, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins.  Medical devices also include diagnostic aids such as reagents and test kits for in vitro diagnosis (IVD) of disease and other medical conditions such as pregnancy.  Clinical investigations of medical devices must comply with FDA informed consent and IRB regulations.  Please note: The FDA regulations apply to ALL medical device studies, whether the device is marketed or not.

2.   What is an investigational medical device?

An investigational medical device is one that is the subject of a clinical study designed to evaluate the effectiveness and/or safety of the device.

3. How are investigational medical devices classified?
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 There are two possible classifications for investigational medical devices:

  • a) Significant Risk (SR) or
  • b) Non-Significant Risk (NSR).

Please see the FDA Information Sheets for examples of SR and NSR devices.

4. What is the Difference between Significant and Non-Significant Risk Devices?

 The distinctions between the two device risk categories are:

 a) A SR device poses a “potential for serious risk to the health, safety, or welfare of a subject.” Such devices may only be studied under an Investigational Device Exemption (IDE) granted by the FDA.  A device is SR (and requires an IDE) if it: 

  •  is intended as an implant, or 
  •  is purported or represented to be for a use in supporting or sustaining human life, or 
  •  is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health; or 
  •  otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. 

b) Non-significant risk devices do not meet the above definition. The assessment of whether or not a device study represents a NSR is initially made by the sponsor/investigator.  The IRB will then determine if the NSR designation is appropriate.  If the IRB disagrees with the NSR claim, it will require the sponsor/investigator to submit an IDE application to the FDA.

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5. Does the FDA Have Ultimate Authority to Determine SR/NSR Classification?

The FDA has the ultimate authority to determine if a device study presents a “significant risk” or “nonsignificant risk.”  If the FDA disagrees with the IRB’s decision that a device study presents a “nonsignificant risk”, an Investigational Device Exemption (IDE) application must be submitted to the FDA before the device is used in a clinical study.  Additionally, if a sponsor/investigator presumes a device to be SR and submits an (IDE) to the FDA, the FDA may disagree and classify the device as “nonsignificant risk.”  In this case, the FDA will return the IDE application with the recommendation that the device should be presented to the IRB as a “nonsignificant risk” device.

6. What is an Investigational Device Exemption (IDE)?
 

An IDE is issued by the FDA to allow the use investigational devices in human subjects. The IDE permits use of the device in a clinical investigation to evaluate the safety and/or efficacy of the investigational medical device. An IDE may be held either by a commercial sponsor or by a physician-investigator.  Clinical studies of SR investigational devices must comply with FDA’s investigational device exemption (IDE) regulations and be conducted only with IRB approval.  More information is available at this site:http://www.fda.gov/. If an investigational device is a “non-significant risk device”, an investigator does not need to submit an IDE; the IDE will be “considered approved” under FDA regulations.  Such devices do not have to comply with FDA premarket approval and performance standards prior to use in research studies. Such studies of devices “considered approved” by the FDA must still be submitted to the IRB for approval prior to use in human subject research.

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7. What is “Compassionate Treatment Use” of a Device under an IDE?
 

The FDA provides procedures for the use of an investigational device outside the parameters of an approved protocol.  In the case of a serious disease, a device may be made available after the completion of all the clinical trials.  If an “immediately life-threatening disease” presents, an investigational device may be made available for treatment use prior to the completion of the research. 

Investigators must contact the FDA to discuss “compassionate treatment” using an investigational device outside of an IRB approved protocol and must obtain IRB approval for this use.  The FDA will consider the use of an investigational device under a treatment IDE if:

a) the device is intended to treat or diagnose a serious or immediately life-threatening disease or condition;
b) there is no comparable or satisfactory alternative device or other therapy available to treat or diagnose that stage of the disease or condition;
c) the device is under investigation in a controlled clinical trial for the same use under an approved IDE, or such clinical trials have been completed;
d) the sponsor of the investigation is actively pursuing marketing approval/clearance of the investigational device with due diligence.

FDA approval of compassionate use of an investigational device must precede use of that device.
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 8. Are there investigational medical devices that are exempt from FDA IDE regulations?
 

There are five possible device studies that are exempt from the FDA regulations on IDEs.  These exemptions apply only so long as the investigator remains qualified to conduct the research (seeFDA regulations, 21 CFR 812.119for Disqualification).

i. Devices, other than transitional devices*, in commercial distribution prior to May 28, 1976, when used or investigated in accordance with labeling in effect at that time;

ii. Devices, other than transitional devices*, introduced into commercial distribution on or after May 28, 1976, that the FDA determines to be substantially equivalent to a device in commercial distribution prior to May 28, 1976, and which is used or investigated in accordance with approved labeling;

iii. A diagnostic device (including in vitro diagnostic products in compliance with21 CFR 809.10(c)if the testing:

a. Is non-invasive
b. Does not require an invasive sampling procedure that presents significant risk
c. Does not by design or intention introduce energy into a subject, and
d. Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.

iv. Devices undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution , if the testing is not for the purpose of  determining safety or effectiveness and does not put the subject at risk.

v. Custom devices, as defined byFDA in 21 CFR 812.3(b),  unless the device is being used to determine safety or effectiveness for commercial distribution.

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9. When must a Sponsor/Investigator apply for an IDE?

 A sponsor/investigator, must submit an application to the FDA for approval of an IDE if:

  • an SR device is to be used in an investigational study,
  • an investigation of a device is proposed to be conducted under the FDA regulations for emergency research,or
  • the FDA notifies the sponsor/investigator that an IDE must be submitted for a proposed investigation

A sponsor/investigator may not begin a study for which FDA approval of an IDE application is required until the FDA has issued its approval and the IRB has approved the study.
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10. What other Medical Device Studies may be conducted without an IDE?

A device with an FDA 510(k) Designation.

FDA regulations allow a manufacturer/sponsor to claim that a new device is substantially equivalent to models that the FDA has already approved for marketing.  Such devices are granted a 510(k) designation.  The manufacturer/sponsor must apply to the FDA for this designation, and the FDA will provide a letter in response indicating whether or not it is granted. IRB approval is still required before an investigator may conduct research using a device with a 510(k) designation.
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11. Do IDE regulations apply if the device has already been approved for a different use?

Yes, the clinical study of a new indication for an already marketed device falls under the IDE regulation.  The JHM IRB must review the device for its new investigational application.  If there are questions, the investigator and/or the IRB may contact the FDA IDE Staff at :

 9200 Corporate Blvd.
Rockville, MD 20850
301-594-1190

12. IRB review of device studies:

Both SR and NSR device studies must be reviewed by a JHM IRB. In the case of an NSR claim, the initial assessment of whether or not the device study is NSR is made by the sponsor/investigator.  The IRB then determines whether that assessment is appropriate. If an NSR study qualifies as “minimal risk” under Federal regulations; then the IRB may choose to use an expedited review procedure. The risk determination made by the IRB will be based upon both the nature of the device AND the proposed use of the device in the study.  The Board’s finding will be documented in the meeting minutes.

All IRB requirements for human subject research apply to any medical device research study conducted at Hopkins regardless of whether investigators seek exemption from IDE requirements.

13.  Does Medicare cover investigational medical devices and related services?

In 1995, the FDA and the Health Care Financing Agency (HCFA), now the Centers for Medicare & Medicaid Services (CMS), entered into an interagency agreement to categorize devices in clinical trials for purposes of eligibility for coverage by Medicare.  There are two categories of devices: Category A (experimental/investigational devices for which there is no Medicare coverage); and Category B (non-experimental investigational devices).  FDA will notify the sponsor (whether a commercial sponsor or a physician-investigator) of an investigational device clinical trial (i.e., a device with an IDE) of its decision regarding the category assigned to a device.

Category B devices will be eligible for Medicare coverage.  The rule states that: "Payment for covered devices and related services will be based on, and may not exceed, the amount that would have been paid for a currently used FDA-approved device and related services serving the same medical purpose."  NSR device investigations for which the FDA does not require submission of an IDE are deemed to be in Category B.  The JHM IRB must make the decision as to whether a device is SR or NSR. 

Medicarewill not provide payment for Category A devices, and will not pay for "services related to a non-covered device."  Investigators who wish to conduct clinical trials of devices that are determined to be Category A devicesmust address cost issues with the sponsorto assure that Medicare patients are not adversely affected by the decision to participate.

* Per FDA regulations, a transitional device is one that the FDA considered to be a new drug or an antibiotic drug before May 28, 1976
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Sours: https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/devices.html

You will also be interested:

Investigational device exemption

An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study[1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA).[2] Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

Clinical evaluation of devices that have not been cleared for marketing requires:

  • An IDE approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by FDA
  • Informed consent from all patients
  • Labeling for investigational use only
  • Monitoring of the study and
  • Required records and reports

An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would apply to devices in commercial distribution. Sponsors need not submit a PMA or premarket notification, register their establishment, or list the device while the device is under investigation. Sponsors of IDEs are also exempt from the Quality System (QS) Regulation except for the requirements for design control.

A commercial sponsor of a significant risk device study must submit a complete IDE application to FDA. There are no preprinted forms for an IDE application; however, an IDE application must include certain required information. The sponsor must demonstrate in the application that there is reason to believe that the risks to human subjects from the proposed investigation are outweighed by the anticipated benefits to subjects and the importance of the knowledge to be gained, that the investigation is scientifically sound, and that there is reason to believe that the device as proposed for use will be effective.

See also[edit]

References[edit]

Sours: https://en.wikipedia.org/wiki/Investigational_device_exemption


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