Study risk determination

It is one of the Q-Submission types. Asking early avoids starting a study as nonsignificant risk and later finding that an IDE was needed.

A Study Risk Determination is a request for FDA determination for whether a planned medical device clinical investigation is significant risk (SR), nonsignificant risk (NSR), or exempt from most requirements under the IDE regulations (see 21 CFR part 812).

FDA guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (May 2025), Section II.C, Study Risk Determinations