HCT/Ps refers to human cell, tissue, and cellular and tissue-based products, as defined in 1271.3 of this chapter. An HCT/P that is not solely regulated under section 361 of the Public Health Service Act may be a constituent part of a combination product. Such an HCT/P is subject to part 1271 of this chapter and is also regulated as a drug, device, and/or biological product.


21 CFR § 4.2

Scoping language

The terms listed in this section have the following meanings for purposes of this subpart:

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