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
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
