# 21 CFR § 1271.21: When do I register, submit an HCT/P list, and submit updates?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-1271.21

## Section

- **Citation:** 21 CFR § 1271.21
- **Heading:** When do I register, submit an HCT/P list, and submit updates?
- **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 B—Procedures for Registration and Listing

## Text

(a) You must register and submit a list of every HCT/P that your establishment manufactures within 5 days after beginning operations or within 30 days of the effective date of this regulation, whichever is later.
(b) You must update your establishment registration annually in December, except as required by § 1271.26. You may accomplish your annual registration in conjunction with updating your HCT/P list under paragraph (c) of this section.
(c)(i) If no change described in § 1271.25(c) has occurred since you previously submitted an HCT/P list, you are not required to update your listing.
(ii) If a change described in § 1271.25(c) has occurred, you must update your HCT/P listing with the new information:
(a) At the time of the change, or
(b) Each June or December, whichever month occurs first after the change.
[69 FR 68681, Nov. 24, 2004]

## 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-21-1271.21. Check the current official text before relying on it. Not legal advice.