FDA Guidance for Industry and FDA Staff Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products
Title:
FDA Guidance for Industry and FDA Staff Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products
Origin/Publisher:
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Document Type:
Draft Guidance
Content:
recommendations for applying Title 21 of the Code of Federal Regulations (CFR) Part 1271, specifically the
21 CFR 1271.10(a)(2) criterion of homologous use.