Articles
Regulatory Considerations for HCT/Ps
Jul 01, 2020
Minimal Manipulation GUIDANCE FOR FOOD AND DRUG ADMINISTRATIVE STAFF We, FDA, are providing you, human cells, tissues, and cellular and… Read More >
Surgical Procedure Exception: 21 CFR 1271.15(b)
Nov 01, 2017
We, the Center for Biologics Evaluation and Research (CBER)1 at the FDA, are issuing this guidance to provide you, tissue… Read More >
Deviation Reporting for HCT/Ps
Sep 01, 2017
Deviation Reporting for HCT/Ps under PHS Act and 21 CFR 1271 GUIDANCE FOR INDUSTRY We, the Food and Drug Administration… Read More >
Donors of Human-Derived Clotting Factors
Nov 01, 2016
Revised Eligibility Guidelines: Donors of Human-Derived Clotting Factors GUIDANCE FOR INDUSTRY This guidance provides you, establishments that make donor eligibility… Read More >
Adverse Reactions Reporting for HCT/Ps
Mar 01, 2016
GUIDANCE FOR INDUSTRYÂ We, FDA, are issuing this guidance to provide establishments1 that manufacture human cells, tissues, and cellular and… Read More >
Donor Screening for Treponema Pallidum Infection
Sep 01, 2015
GUIDANCE FOR INDUSTRY We, FDA, are providing you, establishments that make donor eligibility determinations for donors of human cells, tissues… Read More >
Tissue Requirements for HCT/Ps Manufacturers
Dec 01, 2011
GUIDANCE FOR INDUSTRY We, FDA, are issuing this guidance to provide you, establishments that manufacture human cells, tissues, and cellular… Read More >
HCT/Ps from Donors Tested for Communicable Diseases
Apr 01, 2008
GUIDANCE FOR INDUSTRYÂ This guidance provides you, an establishment1 that makes donor eligibility determinations for certain human cells, tissues, and… Read More >
HCT/Ps Regulation: Small Entity Compliance Guide
Aug 07, 2007
GUIDANCE FOR INDUSTRY The Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the… Read More >
Donor Eligibility for HCT/Ps
Aug 01, 2007
GUIDANCE FOR INDUSTRY We, FDA, are issuing this guidance to assist you, establishments making donor eligibility determinations, with complying with… Read More >