Institutional Review Board for Health Sciences Research (IRB-HSR)

Special Issues

INVESTIGATIONAL MEDICAL DEVICES

Background
Device Decision Tree
Medical Device Definition
Medical Device Classes
Exemption for Devices
Significant (SR) and Non-Significant Risk Devices
Who Must Apply for an IDE?
Unanticipated Adverse Device Effect Reports
Emergency Use of a Device
Other Types of IDE's

Device Study Record Requirements
Investigators as Sponsors
IDE Applications
Required Approval Process to Use a New Device at UVa Health System

Device Summary Table

Background

All clinical investigations of devices must have an approved IDE (Investigational Device Exemption) from the FDA or be exempt from the IDE regulations. 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:

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

Medical Device Definition

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 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 -

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.

Medical Device Classes

In 1976, Medical Device Amendments to the Food, Drug and Cosmetic Act gave the FDA the responsibility for assuring the safety and effectiveness of devices intended for human use. In implementing these Amendments, the FDA has classified devices according to their level of risk.

Class 1 Medical Devices

Class 1 Medical Devices include those devices for which safety and effectiveness can be assured as long as there is compliance with provisions for notification of defects, repair, replacement or refund, records and reports. Device manufacturers are required to also avoid distribution of adulterated, misbranded, or banned devices.

Class 2 Medical Devices

Class 2 Medical Devices are those that require something more than proper labeling and quality assurance to ensure their safety and effectiveness.

Class 3 Medical Devices

Class 3 Medical Devices are those that are life-sustaining, life-supporting, implanted in the body, or of substantial importance in preventing impairment.

510(K) Devices

When a new device is substantially equivalent to one marketed prior to enactment of the Medical Devices Amendments (1976), it may be sold without additional proof of safety and effectiveness under Section 510(K) of the Federal Food, Drug and Cosmetic Act. These devices are commonly referred to as "510(K) devices." A sponsor planning to market the device must notify the FDA 90 days in advance of placing the device on the market. If the FDA agrees that the device is substantially equivalent to one already on the market, the device may then be sold without further research. Research activities involving a 510(K) device do not require an FDA Investigational Device Exemption (IDE) prior to approval by the IRB.

If the FDA determines that a new device is not substantially equivalent to a pre-amendment device, the new device is automatically designated a Class 3 medical device and the sponsor is required to obtain pre-marketing approval from the FDA. Studies conducted to develop safety and effectiveness data for such devices must be conducted according to the FDA requirements or Investigational Devices.

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:

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

    • 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.
    Additional guidance for an in vitro diagnostic device studies can be found in "Regulating In Vitro Diagnostic Device (IVD) Studies."Regulating In Vitro Diagnostic Device (IVD) Studies."  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072277.htm

  4. 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;

  5. a device intended solely for veterinary use;

  6. 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."

  7. a custom device
  8. 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:

      (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.

    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 56 and 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.