Guidance for Industry
Eligibility Determination for Donors of
Human Cells, Tissues, and Cellular
and Tissue-Based Products (HCT/Ps)
Additional copies of this guidance are available from the Office of Communication, Training and
Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, or by calling 1-800-835-4709 or 301-827-1800, or from the Internet at
http://www.fda.gov/cber/guidelines.htm.
For questions on the content of this guidance, contact the Division of Human Tissues, Office of
Cellular, Tissue and Gene Therapies at 301-827-2002.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research
August 2007
Contains Nonbinding Recommendations
Table of Contents
I.
INTRODUCTION............................................................................................................. 1
II.
BACKGROUND ............................................................................................................... 2
A. What is the scope of this guidance?........................................................................... 2
B. Who should read this guidance?................................................................................ 2
III. THE DONOR-ELIGIBILITY DETERMINATION (§ 1271.50) ................................. 2
A. What is a donor-eligibility determination?............................................................... 2
B. Who makes the donor-eligibility determination? .................................................... 3
C. What are “relevant communicable disease agents or diseases (RCDADs)”?........ 3
D. What communicable disease agents or diseases, not listed in § 1271.3(r)(1), have
been determined to be relevant?................................................................................ 5
E.
How will FDA handle other emerging infectious diseases in regard to HCT/P
donor eligibility? ........................