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.

Summary

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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3 official files

• Introduced in House (text)

  Introduced in House · EN · 7 March 2022

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• Introduced in House (PDF)

  Introduced in House · EN · 7 March 2022

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• Introduced in House

  summary · EN · 7 March 2022

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