Articles
Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements
Sep 01, 2006
GUIDANCE FOR INDUSTRY We, FDA, are issuing this guidance to emphasize to you, establishments that manufacture human cells, tissues, and… Read More >
Donor Screening with Cadaveric Blood in HCT/Ps
Nov 01, 2004
Communicable Disease Donor Screening with Cadaveric Blood in HCT/Ps GUIDANCE FOR INDUSTRY This guidance provides to you, medical device manufacturers… Read More >
Validation for Human Tissue Processing
Mar 01, 2002
GUIDANCE FOR INDUSTRY This guidance document applies to you, all tissue establishments. We, the Food and Drug Administration (FDA), want to… Read More >
HCT/Ps Establishment Registration – Regenative Labs
Jan 19, 2001
A RULE BY THE FOOD AND DRUG ADMINISTRATION The Food and Drug Administration (FDA) is issuing a final rule to… Read More >