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).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.