Research with Medical Devices

An investigational device study is considered to be IDE Exempt (i.e. exempt from IDE requirements) when the device meets any of the following criteria:

• It is a legally marketed device being used in accordance with its labeling;
• It is a diagnostic device that complies with the labeling requirements in 21 CFR 809.10(c), and for the testing of the device all of the following statements are true:
  • It is non-invasive,
  • It does not require an invasive sampling procedure that presents significant risk,
  • It does not by design or intention introduce energy into a subject, and
  • It is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure; or
• The study includes consumer preference testing, testing of a modification, or testing of a combination of devices that are legally marketed devices [that is, the device(s) have an approved PMA, cleared Premarket Notification (510k), or are exempt from 510k] AND the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk.

When applied to a diagnostic device or procedure, non-invasive means one that does not by design or intention:

1. penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra, or
2. 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. For purposes of this part, 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. 21 CFR 812.3(k)

The FDA defines a Significant Risk device as 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.

Significant Risk device studies must have an Investigational Device Exemption (IDE) application approved by the FDA before they proceed.

The FDA considers an NSR device investigation as one that does not meet the definition of a significant risk device study. The term non-significant risk should not be confused with minimal risk. NSR device studies do not require an IDE submission, but must follow the abbreviated FDA requirements at 21 CFR 812.2(b).

The assessment of whether a medical device study presents significant or non-significant risk is initially made by the sponsor. The risk determination should be based on the proposed use of a device in an investigation, and not on the device alone.

If the sponsor considers the device to involve non-significant risk in a particular study, the sponsor provides the reviewing IRB an explanation of its determination and any other information that may assist the IRB in evaluating the risk of the study.

The sponsor should provide the IRB with the following:

• a description of the device,
• reports of prior investigations with the device,
• the proposed investigational plan,
• a description of patient selection criteria and monitoring procedures,
• any determinations made by other IRBs that have reviewed the proposed study (if applicable), and
• any other information that the IRB deems necessary to make its decision.

The IRB may also consult with FDA in making this determination, or ask the investigator to request an SR/NSR determination from the FDA. If either the IRB or FDA determined the study to involve a significant risk device, the sponsor must submit an IDE application to the FDA for approval.

• Externally Worn Insulin Monitors
• Magnetic Resonance Imaging (MRI)
• Daily Wear Contact Lenses and Associated Lens Care Products
• Conventional Implantable Vascular Access Devices (Ports)
• Dental Filling Materials
• Electroencephalography
• General Urological Catheters
• Transcutaneous Electric Nerve Stimulation (TENS) Devices
• Menstrual products
• Wound Dressings (excluding absorbable hemostatic devices/dressings and interactive wound and burn dressings)
• Conventional Laparoscopes, Culdoscopes, and Hysteroscopes
• Conventional Gastroenterology and Urology Endoscopes and Accessories
• Ob/Gyn Diagnostic Ultrasound within FDA approved parameters
• Non-implantable Electrical Incontinence Devices
• Non-implantable Male Reproductive Aids with no components that enter the vagina
• Jaundice Monitors for Infants

The sponsor-investigator responsibilities for a non-significant risk study include:

• Properly labeling the device (The labeling must include the name and address of device manufacturer and “CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.”);
• Obtaining IRB approval with a Non-Significant Risk determination;
• Obtaining informed consent from each participant in the study;
• Monitoring the investigation;
• Maintenance of accurate, complete and current records relating to the investigation;
• Timely submission of reports to the FDA:
  • Unanticipated adverse device effects (10 working days of learning of event),
  • Withdrawal of IRB approval (5 working days of receipt of notice of withdrawal),
  • Any request for the return, repair or disposal of any units of a device (30 working days after request is made); and
• Reporting to the IRB:
  • Progress report (at least annually),
  • Final report (within 6 months of completion or termination of investigation).

• Protect the rights, safety, and welfare of participants under the PD's care;
• Personally conduct or supervise the studies;
• Ensure the studies are conducted in accordance with the relevant, current protocol(s) and only make changes in a protocol after notifying the sponsor, except when necessary to protect the safety, the rights, or welfare of participants;
• Inform participants that the device is being used for investigational purposes and ensure that the requirements relating to obtaining informed consent and IRB review and approval are met
• Informed consent and enrollment into the study will not occur until before IRB and FDA approval are in place.
• Ensure that an investigation is conducted according to the signed statement, the investigational plan, and applicable regulations.

• Maintain control of device under investigation;
• Permit the use of the investigational device only with participants under the PD's personal supervision or under the supervision of a sub-investigator responsible to the PD;
• Do not supply the investigational device to any person not authorized to receive it;
• Maintain adequate records of receipt, use or disposition of a device that relate to the type and quantity of the device, the dates of its receipt, and use by participants;
• If the investigation is terminated, suspended, discontinued, or completed, return the unused supplies of the device to the sponsor, or otherwise dispose of the device as the sponsor directs.

• Prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual receiving the investigational device;
• Maintain all correspondence with other investigators, the IRB, the sponsor, a monitor, or FDA;
• Documentation and submission of all protocol deviations, including the dates and reasons for the deviation, to the sponsor;
• Documentation and submission of all adverse device effects (whether anticipated or unanticipated) and complaints to the sponsor;
• Submission annual progress reports and a final report within 3 months after termination or completion of the investigation to the sponsor and IRB;
• Retain records for a period of 2 years after which records are no longer required for the purposes of supporting a premarket notification submission or other such applications; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is terminated or completed.