U.S. Department of Health & Human Services
Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception
Guidance for industry
United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
Silver Spring, MD : Center for Biologics Evaluation and Research, November 2017
Autografts -- standards
Biological Products -- standards
Biological Products -- therapeutic use
Transplants -- standards
Prostheses and Implants -- standards
Surgical Procedures, Operative
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
The National Library of Medicine believes this item to be in the public domain.
1 online resource (1 PDF file (8 pages)).
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