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

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

June 2006

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

January 2006
In this Technical Brief:
Product Type(s):

  • Medical Device
Topic(s):

  • IRB
  • Clinical Investigator
  • Sponsor
  • Information Sheet
Region(s):

  • United States

Full Info:


Resource Type:

Guidance Document

Citation:

U.S. Department of Health and Human Services, Food and Drug Administration

Authors: 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

Health Risks(s):

  • HIV
  • STI / STD
  • Unintended Pregnancy

Product type(s):

  • MPTs

Topic(s):

  • Development
  • Regulatory

Region(s)

  • United States

URL of resource:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/significant-risk-and-nonsignificant-risk-medical-device-studies

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