To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to promulgate rules to update certain regulations relating to human cells, tissues, and cellular and tissue-based products, and for other purposes.
Referred to the Subcommittee on Health.
Congressional Research Service
Official summary
Version 00 · Introduced in House · Mar 7, 2022
This bill requires the Food and Drug Administration to update its regulations relating to the manufacture of human cells, tissue, and cellular and tissue-based products (HCT/Ps), including an update to the definition of minimal manipulation. (The regulations are commonly referred to as the tissue rules; HCT/Ps that are minimally manipulated and meet other criteria are not regulated as drugs, devices, or biologics and therefore are not subject to premarket review.)
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Feb 5, 2024. Consult Congress.gov for the current record.
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