2022-03-07 Introduced in House 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.)

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