FDA Guidance

The FDA's Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) was released in August 2007.

Visit the FDA Web site to view a copy of this document online.

The federal guidance assists establishments in complying with donor eligibility determinations as set forth in Title 21 Code of Federal Regulations, part 1271, subpart C. This guidance applies to cells and tissues procured on or after May 25, 2005.

ViroMed offers testing for HCT/P donors. For more information about ViroMed’s comprehensive menu of donor testing services, please call Account Management at 800-582-0077.