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Minimal Risk Review Device Studies

Some studies of medical devices qualify for expedited review via Schulman’s Minimal Risk Review service.

In order for a study of an approved/marketed medical device to qualify for expedited review:

  • The study must involve no more than minimal risk.
  • The study may not be testing the safety or effectiveness of the device.
  • The data from the study may not be used to support a safety or effectiveness labeling claim.

In order for a study of an investigational medical device to qualify for expedited review:

  • The study is not a “clinical investigation” as described under 21 CFR 56.102(c) OR the device as used in the study is exempt from the IDE regulations as described under 21 CFR 812.2(c).
  • The study must involve no more than minimal risk.
  • The study may not be testing the safety or effectiveness of the device.
  • The data from the study may not be used to support a safety or effectiveness labeling claim.

The submission of an investigational medical device must include a signed and dated letter explaining why the study of the device is exempt from the IDE regulations as described under 21 CFR 812.2(c). If the submission is not a study of device safety and effectiveness, the IDE regulations do not apply. Please see Submitting a Device Study for more information.

Studies of non-significant risk (NSR) devices will not be reviewed by expedited review, even when the study involves no more than minimal risk to human subjects. The device risk determination (significant risk vs. NSR) must be evaluated at a full Board meeting.

To ask questions about submitting your device study to Schulman, please contact Business Development or call 513.761.4100.