# Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/regulatory-considerations-for-human-cells-tissues-and-cellular-and-tissue-based-products-minimal-manipulation-and-homologous-use-guidance-for-industry-and-food-and-drug-administration-staff/29251db7-6c74-4d63-affc-a906cc2d1efa

> FDA guidance document: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use:  Guidance for Industry and Food and Drug Administration Staff. Issue date: July 20, 2020. Get complete insights and analysis.

---

## Details

- Title: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use:  Guidance for Industry and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2020-07-20
- Last Changed: 2020-07-21
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-6146">FDA-2017-D-6146</a>

## Related Documents

- [Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices:   Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/use-of-real-world-evidence-to-support-regulatory-decision-making-for-medical-devices-guidance-for-industry-and-food-and-drug-administration-staff/d18b3a42-ad8b-4987-8955-ea08f4372049)
- [Testing for Biotin Interference in In Vitro Diagnostic Devices:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/testing-for-biotin-interference-in-in-vitro-diagnostic-devices-guidance-for-industry/1a6a74f2-3b19-490b-9847-11a56bd093bf)
- [Evaluation of Devices Used with Regenerative Medicine Advanced Therapies:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/evaluation-of-devices-used-with-regenerative-medicine-advanced-therapies-guidance-for-industry/0bd9718e-c6aa-4925-902b-f84e80a50ef9)
