U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Significant Risk and Nonsignificant Risk Medical Device Studies
  1. Search for FDA Guidance Documents

INFORMATION SHEET

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

Final
Docket Number:
FDA-2006-D-0031
Issued by:
Guidance Issuing Office
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, 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

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:

Dockets Management
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.