Articles
Regulatory Considerations for HCT/Ps: Minimal Manipulation – Regenative Labs
Jul 01, 2020
GUIDANCE FOR FOOD AND DRUG ADMINISTRATIVE STAFF We, FDA, are providing you, human cells, tissues, and cellular and tissue-based product… Read More >
Surgical Procedure Exception: Q&A under 21 CFR 1271.15(b) – Regenative Labs
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 under PHS Act and 21 CFR 1271 – Regenative Labs
Sep 01, 2017
GUIDANCE FOR INDUSTRY We, the Food and Drug Administration (FDA), are issuing this guidance to provide you, establishments that manufacture… Read More >
Revised Eligibility Guidelines: Donors of Human-Derived Clotting Factors
Nov 01, 2016
GUIDANCE FOR INDUSTRY This guidance provides you, establishments that make donor eligibility (DE) determinations for donors of human cells, tissues,… Read More >
Adverse Reactions Reporting for HCT/Ps
Mar 01, 2016
GUIDANCE FOR INDUSTRY 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 >
Good Tissue Practice & 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 INDUSTRY 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 – Regenative Labs
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 >