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# HCT/P Manipulation and Homologous Use Guidance
- URL: https://www.fdaweb.com/hct-p-manipulation-and-homologous-use-guidance/
- Published: 2020-07-21T12:00:00.000Z
- Updated: 2026-09-14T16:21:50.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147247

FDA has issued a guidance, *Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use*, outlining the agency’s current thinking on the regulatory criteria for minimal manipulation and homologous use. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal?ref=fdaweb.com) supersedes one that was issued 11/2017 and corrected 12/2017\. It revises Section V to extend the period of enforcement discretion through 5/31/21, FDA says.

The agency says the guidance is intended to improve stakeholders’ understanding of the definition of minimal manipulation and homologous use in the regulations and to facilitate stakeholder understanding of how the regulatory criteria apply to their human cells, tissues, and cellular and tissue-based products.