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Human Cell/Tissue-Based Products

US FDA final rule published on donor suitability

On 25 May 2004, the US Food and Drug Administration (FDA) published in the Federal Register a final rule establishing criteria for donors of human cells, tissues and cellular- and tissue-based products (HCT/Ps), to be implemented under the proposed comprehensive regulatory framework for HCT/Ps1-3. The rule also amends the current good manufacturing practice (cGMP) and quality systems (QS) regulations that apply to HCT/Ps regulated as drugs, medical devices and/or biologics, to clarify the role of the new donor-eligibility regulations in relation to existing cGMP regulations.

The rule extends the requirements for screening and testing, already incumbent on establishments dealing with human tissue intended for transplantation, such as muscular, skin and ocular tissue, to those dealing...

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