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:
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: