# Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Small Entity Compliance Guide; Availability
> **Food and Drug Administration** · Notification of availability. · Published 2022-11-01 · 87 FR 65681
## Document
- **Document number:** 2022-23573
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 87 FR 65681
- **CFR reference:** 21 CFR 1271
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2022/11/01/2022-23573/regulation-of-human-cells-tissues-and-cellular-and-tissue-based-products-small-entity-compliance)
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