Human cells, tissues, or cellular or tissue-based product regulated as a device (HCT/P)

This is the 21 CFR 801 wording of the same concept. It brings these products under the device labeling and UDI rules.

Human cells, tissues, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in § 1271.3(d) of this chapter that does not meet the criteria in § 1271.10(a) and that is also regulated as a device.

21 CFR, 801.3