# Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing
> **Food and Drug Administration** · Final rule. · Published 2001-01-19 · Effective 2001-04-04 · 66 FR 5447
## Document
- **Document number:** 01-1126
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 66 FR 5447
- **CFR reference:** 21 CFR 207
- **Publication date:** 2001-01-19
- **Effective date:** 2001-04-04
- **HHS docket:** Docket No. 97N-484R
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule to require human cells, tissue, and cellular and tissue-based product establishments to register with the agency and list their human cells, tissues, and cellular and tissue-based products. FDA is also amending the registration and listing regulations that currently apply to human cells, tissues, and cellular and tissue-based products regulated as drugs, devices, and/or biological products. These actions are being taken to establish a unified registration and listing program for human cells, tissues, and cellular and tissue-based products.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2001/01/19/01-1126/human-cells-tissues-and-cellular-and-tissue-based-products-establishment-registration-and-listing)
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