Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products
other · Food and Drug Administration · Rule · Published 2016-06-22 · Effective 2016-08-22 · 81 FR 40512
Document
Document number
2016-14721
Federal Register citation
81 FR 40512
CFR reference
21 CFR 1271
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2016-06-22
Effective date
2016-08-22
HHS docket
Docket No. FDA-2014-N-1484
Abstract
The Food and Drug Administration (FDA or Agency or we) is issuing this final rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. This final rule is in response to our enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos.