Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
other · Food and Drug Administration · Rule · Published 2005-05-25 · Effective 2005-05-25 · 70 FR 29949
Document
Document number
05-10583
Federal Register citation
70 FR 29949
CFR reference
21 CFR 1271
Type
Rule
Action
Interim final rule; opportunity for public comment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2005-05-25
Effective date
2005-05-25
HHS docket
Docket No. 1997N-0484T
Abstract
The Food and Drug Administration (FDA) is issuing an interim final rule to amend certain regulations regarding the screening and testing of donors of human cells, tissues, and cellular and tissue- based products (HCT/Ps), and related labeling. FDA is taking this action in response to comments from affected interested persons regarding the impracticability of complying with certain regulations as they affect particular HCT/Ps.