May 28, 2004
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FDA Finalizes New Rule on Donor Eligibility for Human Tissues and Cells

Food and Drug Administration FDA recently published a final rule establishing donor eligibility criteria for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) to help prevent the transmission of communicable disease when these products are transplanted. This new rule is the second of three proposed rules that have been finalized as part of the Agency's plan to regulate tissues and related products with a comprehensive, risk-based approach. The requirements are comprehensive, yet adequately flexible, and they provide needed protections for patients without imposing unnecessary regulation.

The final rule becomes effective on May 25, 2005. It is accompanied by draft guidance that provides recommendations for complying with the requirements in the donor eligibility rule. Comments on the draft guidance should be received by August 23, 2004.

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