Subjects: Equipment Safety -- classification - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Equipment Safety -- classification ✖

1. De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 30, 2017
Subject(s):: Classification
Device Approval -- standards
Equipment and Supplies -- classification
Equipment Safety -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
Subject(s):: Cost-Benefit Analysis
Device Approval
Equipment and Supplies -- classification
Equipment Safety -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.