Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Small Entity Compliance Guide; Availability
other · Food and Drug Administration · Rule · Published 2022-11-01 · 87 FR 65681
Document
Document number
2022-23573
Federal Register citation
87 FR 65681
CFR reference
21 CFR 1271
Type
Rule
Action
Notification of availability.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2022-11-01
HHS docket
Docket No. FDA-2022-D-0563
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps): Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entity establishments that manufacture HCT/Ps better understand the comprehensive regulatory framework for HCT/Ps set forth in the regulations and comply with certain HCT/P- related final rules. The SECG announced in this notice supersedes the SECG of the same title dated August 2007.