1. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, November 2017 Subject(s): Autografts -- standardsBiological Products -- standardsBiological Products -- therapeutic useTissue TransplantationTransplantation, AutologousTransplantation, HomologousTransplants -- standardsProstheses and Implants -- standardsSurgical Procedures, OperativeHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, July 2020 Subject(s): Biological ProductsTissuesCell- and Tissue-Based TherapyTissue TransplantationUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
