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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 (HCT/Ps) Guidance for Industry November 2004

Final

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)

Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance provides to you, medical device manufacturers of communicable disease tests, information about performing studies to support modifying the indication for use to include testing of cadaveric blood pecimens to screen donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). This guidance makes recommendations about: 

• Sensitivity and specificity studies • Reproducibility studies • Number of test kit lots to include in studies
• Plasma dilution issues
• Information about specimen collection times to be included


This document contains information which has been provided in Center for Biologic Evaluation and Research’s (CBER’s) letters to manufacturers of communicable disease tests. We, FDA, continue to encourage Manufacturers of communicable disease tests to evaluate these tests for cadaveric HCT/P donor use and seek such labeling.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010