This submission by AABB, America’s Blood Centers, and the American Red Cross to the U.S. FDA regarding the draft guidance for determining eligibility of donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) includes three main comments:
- Support for the draft guidance recommendations.
- Support for the updated guidance format.
- Request for an extended implementation period of at least one year to facilitate the necessary updates and training for compliance with the new recommendations.
Posted in Letters and Comments