# Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/certain-human-cells-tissues-and-cellular-and-tissue-based-products-hctps-recovered-from-donors-who-were-tested-for-communicable-diseases-using-pooled-specimens-or-diagnostic-tests-guidance-for-industry/2badf630-8585-45e0-8caf-a8078914403e

> FDA guidance document: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests:  Guidance for Industry. Issue date: April 16, 2008. Get complete insights and analysis.

---

## Details

- Title: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests:  Guidance for Industry
- 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: 2008-04-16
- Last Changed: 2024-04-23
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2007-D-0070">FDA-2007-D-0070</a>

## Related Documents

- [Compliance with 21 CFR Part 1271150(c)(1) – Manufacturing Arrangements:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/compliance-with-21-cfr-part-1271150c1-manufacturing-arrangements-guidance-for-industry/21f3b771-082c-4fa4-bcb3-11816cc92176)
- [Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps):  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/recommendations-for-obtaining-a-labeling-claim-for-communicable-disease-donor-screening-tests-using-cadaveric-blood-specimens-from-donors-of-human-cells-tissues-and-cellular-and-tissue-based-products-hctps-guidance-for-industry/2565c7c9-cea3-4b8f-b6bd-75572e27c93d)
- [General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/general-principles-for-the-development-of-vaccines-to-protect-against-global-infectious-diseases-guidance-for-industry/b31a8d12-c66e-47ea-8023-d4945a51137e)
