---
kind: "section"
citation: "21 C.F.R. § 1271.20"
title: "21"
number: "1271.20"
heading: "If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?"
url: "https://uscodex.org/cfr/21/1271.20"
---

# §1271.20. If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?


If you are an establishment that manufactures an HCT/P that does not meet the criteria set out in [§ 1271.10(a)](/cfr/21/1271.10.md?p=a), and you do not qualify for any of the exceptions in [§ 1271.15](/cfr/21/1271.15.md), your HCT/P will be regulated as a drug, device, and/or biological product under the act and/or section 351 of the PHS Act, and applicable regulations in [title 21](/cfr/21.md), chapter I. Applicable regulations include, but are not limited to, §§ [207.9(a)(5)](/cfr/21/207.9.md?p=a-5), [210.1(c)](/cfr/21/210.1.md?p=c), [210.2](/cfr/21/210.2.md), [211.1(b)](/cfr/21/211.1.md?p=b), [807.20(d)](/cfr/21/807.20.md?p=d), and [820.1(a)](/cfr/21/820.1.md?p=a) of this chapter, which require you to follow the procedures in subparts [C](/cfr/21/subpartC.md) and [D](/cfr/21/subpartD.md) of this part.


## Notes

### Amendments

[66 FR 5466, Jan. 19, 2001, as amended at 81 FR 60223, Aug. 31, 2016]

### Authority

Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

### Source

Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.

### Amendments

[66 FR 5466, Jan. 19, 2001, as amended at 81 FR 60223, Aug. 31, 2016]