Is Your Study IDE exempt or Non-Significant Risk (NSR)?

Questions? Contact Clinical Trials Regulatory Support

Overview

While clinical investigations of medical devices require compliance with IDE requirements, your study may be exempt from IDE requirements under one of the IDE Exempt categories or considered Non-Significant Risk, which does not require an IDE submission to the FDA.

Step1

Review the FDA approval/clearance status and indications of the device to be studied

See FDA guidance for background on device classification:

Search FDA Medical Device Databases for your device or similar devices:

  1. 510K cleared database
  2. 510k exempt database
  3. PMA database
  4. De Novo database

Step2

Consider the FDA categories and criteria for IDE exemption

The FDA criteria for IDE exemption can be reviewed at 21 CFR 812.2(c) external site (opens in a new window) and are summarized below. The IDE requirement does not apply to investigations of the following categories of devices:

  1. Older devices: A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time.
  2. Legally marketed devices (510(k) exempt, 510(k) cleared, PMA, HDE, De Novo) being used on label
  3. A diagnostic device, if the sponsor complies with applicable requirements in § 809.10(c) and if the testing:
    1. Is noninvasive,
    2. Does not require an invasive sampling procedure that presents significant risk,
    3. Does not by design or intention introduce energy into a subject, and
    4. Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.
  4. A device 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 subjects at risk.
  5. Not for human use: A device intended solely for veterinary use.
  6. Not for human use: A device shipped solely for research on or with laboratory animals and labeled in accordance with § 812.5(c).
  7. A custom device as defined in § 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.

Step3

Consider the FDA criteria for Non-Significant Risk (NSR) devices

If your study is not IDE exempt, is it NSR? To be Non-Significant Risk (NSR), the use of the device in the proposed study cannot involve any of the FDA criteria for a "significant risk device" as defined at 21 CFR 812.3(m), which is 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.

See FDA Guidance:

Step4

Complete the IDE Device Checklist

Sponsor-Investigators are responsible for making the initial device risk assessment and presenting it to the Institutional Review Board (IRB) for a risk determination. The FDA is also available to help the sponsor, clinical investigator, and IRB in making the risk determination.

  1. Section A: Does the proposed use of the device meet any of the IDE exemption categories (Categories 2 and 3 are the most common)?
  2. Section B: Provide a rationale for why the use of the device does not meet significant risk criteria, if applicable.

If neither the exempt categories nor the NSR criteria are satisfied for the device, the Sponsor-Investigator will need to submit an IDE application to FDA.

Step5

Request that the IRB confirm your determination that the device is IDE exempt or NSR as used in your study

Your IRB submission should include the following:

  • IDE Device Checklist external site (opens in a new window)
  • Email documenting guidance provided by the UCSF Regulatory Support Unit regarding the likely device risk determination, if applicable
  • Documentation of any official guidance provided by FDA indicating that an IDE application is not required (less common)
  • If the IRB does not agree with the sponsor-investigator's assessment that the device is IDE exempt or NSR, an IDE application must be submitted to FDA’s CDRH (Center for Devices and Radiological Health)

FDA Guidance

IDE Definitions and Acronyms

Frequently Asked Questions About Medical Devices

FAQs about Investigational Device Exemption

Significant Risk and Nonsignificant Risk Medical Device Studies