- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical PracticeCenter for Devices and Radiological Health
This guidance is intended to provide advice to sponsors, clinical investigators, and institutional review boards (IRBs) on how to determine the differences between significant risk and nonsignificant risk medical device studies. This document supersedes Significant Risk and Nonsignificant Risk Medical Device Studies (September 1998) Office of Health Affairs, Food and Drug Administration. This document was revised to update the list of examples of significant and nonsignificant risk devices, to clarify the IRB’s responsibilities when making the risk determination for investigational medical devices, and to make the guidance consistent with the Agency’s good guidance practices regulations (21 CFR 10.115).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2006-D-0031.