# 21 C.F.R. § 1271.20 (2026): 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?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_20

## Section

- **Citation:** 21 C.F.R. § 1271.20 (2026)
- **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?
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 1271: HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS / Subpart A: General Provisions / § 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?

## Text

If you are an establishment that manufactures an HCT/P that does not meet the criteria set out in § 1271.10(a), and you do not qualify for any of the exceptions in § 1271.15, 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, chapter I. Applicable regulations include, but are not limited to, §§ 207.9(a)(5), 210.1(c), 210.2, 211.1(b), 807.20(d), and 820.1(a) of this chapter, which require you to follow the procedures in subparts C and D of this part.
[66 FR 5466, Jan. 19, 2001, as amended at 81 FR 60223, Aug. 31, 2016]

## Nearby sections

- [21 C.F.R. § 1271.1 (2026) § 1271.1   What are the purpose and scope of this part?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_1.md)
- [21 C.F.R. § 1271.3 (2026) § 1271.3   How does FDA define important terms in this part?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_3.md)
- [21 C.F.R. § 1271.10 (2026) § 1271.10   Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_10.md)
- [21 C.F.R. § 1271.15 (2026) § 1271.15   Are there any exceptions from the requirements of this part?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_15.md)
- [21 C.F.R. § 1271.20 (2026) § 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?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_20.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_20. Check the current official text before relying on it. Not legal advice.