Is Your Study IDE exempt or NSR?

See FDA guidance for background on device classification:

• Classify Your Medical Device
• How to Study and Market Your Device

Search FDA Medical Device Databases for similar devices:

1. 510K database
2. PMA database
3. De Novo database

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. Substantial equivalence (510(k)) clearance: A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that FDA has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling FDA reviewed under subpart E of part 807 in determining substantial equivalence.
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.

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:

• Significant Risk and Nonsignificant Risk Medical Device Studies
• In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions
• Device Software Functions Including Mobile Medical Applications
• General Wellness: Policy for Low-Risk Devices

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

• Answer the questions in the IDE Device Checklist

1. Section A: Does the proposed use of the device meet any IDE exemption criteria (Categories 2 and 3 are 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.

Your IRB submission should include the following:

• IDE Device Checklist external site (opens in a new window)
• Email documenting guidance provided by UCSF Regulatory Support staff 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)