# 21 CFR § 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?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.20

## Section

- **Citation:** 21 CFR § 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?
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER L—REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION > PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS > Subpart A—General Provisions

## 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 CFR § 1271.1 § 1271.1 What are the purpose and scope of this part?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.1.md)
- [21 CFR § 1271.3 § 1271.3 How does FDA define important terms in this part?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.3.md)
- [21 CFR § 1271.10 § 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/ecfr-21-1271.10.md)
- [21 CFR § 1271.15 § 1271.15 Are there any exceptions from the requirements of this part?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.15.md)
- [21 CFR § 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?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.20.md)
- [21 CFR § 1271.21 § 1271.21 When do I register, submit an HCT/P list, and submit updates?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.21.md)
- [21 CFR § 1271.22 § 1271.22 How do I register and submit an HCT/P list?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.22.md)
- [21 CFR § 1271.23 § 1271.23 How is a waiver from the electronic format requirements requested?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.23.md)
- [21 CFR § 1271.25 § 1271.25 What information is required for establishment registration and HCT/P listing?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.25.md)
- [21 CFR § 1271.26 § 1271.26 When must I amend my establishment registration?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.26.md)
- [21 CFR § 1271.27 § 1271.27 Will FDA assign me a registration number?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.27.md)
- [21 CFR § 1271.37 § 1271.37 Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.37.md)
- [21 CFR § 1271.45 § 1271.45 What requirements does this subpart contain?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.45.md)
- [21 CFR § 1271.47 § 1271.47 What procedures must I establish and maintain?](https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.47.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.20. Check the current official text before relying on it. Not legal advice.