Subjects: Device Approval -- standards and United States. Department of Health and Human Services. - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Device Approval -- standards ✖ Subjects United States. Department of Health and Human Services. ✖

21. Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
Subject(s):: Compassionate Use Trials -- standards
Cost-Benefit Analysis
Device Approval -- standards
Equipment and Supplies -- classification
Uncertainty
Data Collection
Reagent Kits, Diagnostic
Research Design
Sample Size
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

22. Humanitarian device exemption (HDE) program: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 6, 2019
Subject(s):: Compassionate Use Trials -- standards
Device Approval -- standards
Cost-Benefit Analysis
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

23. The Special 510(k) Program: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 13, 2019
Subject(s):: Device Approval -- standards
Therapeutic Equivalency
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.