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INFORMATION SHEET

Significant Risk and Nonsignificant Risk Medical Device Studies Guidance For IRBs, Clinical Investigators, and Sponsors January 2006

Final

Significant Risk and Nonsignificant Risk Medical Device Studies

Issued by:
Guidance Issuing Office
Office of Good Clinical Practice
Center 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). 


Submit Comments

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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.