21 CFR Part 1271 is the FDA regulation that sets registration and listing, donor-eligibility and current good tissue practice (CGTP) requirements for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps). This page is for tissue establishments that are registering, reorganizing or repairing their quality system under it. Once your regulatory counsel has confirmed how your products are classified, Integral Healthcare Solutions (IHS) maps your tissue establishment's obligations to your documents and drafts the procedures; your counsel decides classification.

Last reviewed: October 2026.

What is 21 CFR Part 1271?

Section 1271.1(a) states the purpose: "to create an electronic registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P's) and to establish donor-eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/P's" (eCFR, 21 CFR 1271.1, read as in force on September 30, 2026).

The governing texts:

• 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products: Subparts A and B (registration and listing), Subpart C (donor eligibility), Subpart D (current good tissue practice) and Subpart E (additional requirements).
• FDA's guidance "Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)", Guidance for Industry, December 2011, Final, Docket FDA-2008-D-0659, issued by CBER. FDA states the guidance gives "recommendations for complying with Current Good Tissue Practice (CGTP) requirements under Title 21 Code of Federal Regulations, Part 1271 (21 CFR Part 1271), Subpart D." The page shows "Content current as of: 08/16/2023."

The core CGTP duty, in section 1271.145: "You must recover, process, store, label, package, and distribute HCT/Ps, and screen and test cell and tissue donors, in a way that prevents the introduction, transmission, or spread of communicable diseases." Section 1271.150(a) sets the reach: CGTP requirements "govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps, including but not limited to all steps in recovery, donor screening, donor testing, processing, storage, labeling, packaging, and distribution" (eCFR).

Who needs it and what triggers it

Part 1271 reaches establishments that manufacture HCT/Ps, and "manufacture" covers the full chain from recovery to distribution quoted above. Some products sit outside the section 361 framework: section 1271.10(a) states that "An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria: (1) The HCT/P is minimally manipulated; (2) The HCT/P is intended for homologous use only," and the criteria continue in that section. Section 1271.1(b)(2) points establishments outside those criteria to the drug, biologic and device registration rules in Parts 207 or 807. Section 1271.1(b)(2) also states that 21 CFR 210.1(c), 210.2, 211.1(b) and 820.1(a) require those establishments to comply with the donor-eligibility procedures in Subpart C and the current good tissue practice procedures in Subpart D of Part 1271, in addition to all other applicable regulations. Which side a product falls on is a classification question for your counsel.

There are exceptions; one is: Section 1271.15(b): "You are not required to comply with the requirements of this part if you are an establishment that removes HCT/P's from an individual and implants such HCT/P's into the same individual during the same surgical procedure" (eCFR).

The events that usually start the work:

• A new establishment. Section 1271.21(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."
• The annual cycle. Section 1271.21(b): "You must update your establishment registration annually in December."
• An organizational change, such as a merger, a new site or a new product, that changes which activities the establishment performs.
• Quality system remediation, where procedures no longer match what the establishment does.

How IHS helps

IHS starts after your regulatory counsel has confirmed how your products are classified. The process:

1. Obligation mapping. IHS maps the Part 1271 requirements that apply to your establishment's actual activities, step by step from recovery to distribution.
2. Gap assessment. IHS compares your procedures and records to those requirements and to FDA's December 2011 CGTP guidance.
3. Document and evidence mapping. IHS builds a crosswalk from each applicable requirement to the procedure and record that meets it.
4. Drafting. IHS drafts document controls and donor-record, deviation, tracking and reporting procedures. Technical content is drafted for your tissue specialists to review and approve.
5. Mock document review. IHS reviews the finished set as an outside reviewer would read it, and lists what is still open.

What you supply: counsel's classification decision, your SOPs, and tissue specialists who own donor eligibility, validation and release.

The limit: product classification is counsel's decision, and IHS gives no opinion on it. IHS does not file with FDA. Your establishment makes every FDA registration, listing and report.

What to have ready

Each item ties to 21 CFR Part 1271 as in force on September 30, 2026, or to FDA's CGTP guidance (December 2011, Final).

1. Your counsel's written classification of each product against the section 1271.10(a) criteria.
2. If you rely on the same-surgical-procedure exception in section 1271.15(b), counsel's confirmation that it applies.
3. Your registration and HCT/P listing records, and the date of your last December update under section 1271.21(b).
4. A list of the manufacturing steps you perform, using the steps named in section 1271.150(a): recovery, donor screening, donor testing, processing, storage, labeling, packaging and distribution.
5. The SOP for each of those steps, with its current version and approval date.
6. Your donor-eligibility procedures and records (Subpart C).
7. Your current deviation, tracking and reporting procedures (Subparts D and E).
8. A copy of FDA's CGTP guidance, the version your procedures were written against.
9. Names of the tissue specialists who will review and approve technical content.

The introductory call is the place to walk through this list for your establishment.

How it compares

Part 1271 is regulation. The programs below are private programs or apply to different products, and some establishments hold more than one. This table describes them; it does not say which fits your establishment.

What it costs

The pages we reviewed for this page, 21 CFR Part 1271 and FDA's CGTP guidance, publish no fee schedule. Confirm any registration charges with FDA before you budget.

IHS scopes each engagement after a free introductory call.

What this is not

• This page is not legal advice. IHS is not a law firm and gives no opinion on whether a product is regulated under section 361 or section 351.
• IHS does not register, list, file reports with or correspond with FDA on your behalf. IHS drafts; your establishment files.
• IHS does not make or review donor-eligibility, validation or release decisions.

Frequently asked questions

What is an HCT/P establishment under 21 CFR Part 1271?

Part 1271 covers establishments that manufacture human cells, tissues, and cellular and tissue-based products. Manufacture includes all steps in recovery, donor screening, donor testing, processing, storage, labeling, packaging and distribution, so an establishment that performs any of those steps should read the part closely with counsel.

Is our product regulated solely under section 361, or under section 351?

Section 1271.10(a) states that an HCT/P is regulated solely under section 361 if it meets all of the listed criteria, starting with minimal manipulation and homologous use only. Products that do not meet them are pointed to drug, biologic or device registration under Parts 207 or 807. Section 1271.1(b)(2) also states that 21 CFR 210.1(c), 210.2, 211.1(b) and 820.1(a) require those establishments to comply with the donor-eligibility procedures in Subpart C and the current good tissue practice procedures in Subpart D of Part 1271, in addition to all other applicable regulations. That classification is your regulatory counsel's decision; IHS gives no opinion on it.

When must a tissue establishment register with FDA and update its listing?

Section 1271.21(a) requires registration and a list of every HCT/P the establishment manufactures within 5 days after beginning operations, or within 30 days of the regulation's effective date, whichever is later. Section 1271.21(b) requires the registration to be updated annually in December, except as required by 1271.26. Under 1271.21(c), if a change described in 1271.25(c) has occurred since your last HCT/P list, you must update the listing at the time of the change or each June or December, whichever month occurs first after the change; if no such change has occurred, no listing update is required. Your establishment makes these filings; IHS does not file with FDA.

What are the core current good tissue practice requirements?

Section 1271.145 requires establishments to recover, process, store, label, package and distribute HCT/Ps, and screen and test donors, in a way that prevents the introduction, transmission or spread of communicable diseases. Section 1271.150(a) says CGTP governs the methods, facilities and controls used for every manufacturing step. FDA's December 2011 CGTP guidance gives FDA's recommendations for meeting Subpart D.

Which establishments are exempt from Part 1271?

Section 1271.15 lists six exceptions: (a) establishments that use HCT/Ps solely for nonclinical scientific or educational purposes; (b) removal and implantation into the same individual during the same surgical procedure; (c) carriers; (d) establishments that only receive or store HCT/Ps solely for implantation, transplantation, infusion, or transfer within their own facility; (e) establishments that only recover reproductive cells or tissue and immediately transfer them into a sexually intimate partner of the donor; and (f) an individual under contract with a registered establishment engaged solely in recovering cells or tissues, who need not register or list independently but must comply with the other requirements. Whether any applies is a question for your counsel.

What records and procedures does FDA expect for donor eligibility, deviations and tracking?

Part 1271 places donor eligibility in Subpart C, current good tissue practice in Subpart D and additional requirements in Subpart E, and FDA's 2011 guidance explains its CGTP recommendations. IHS maps those subparts to your activities and drafts the donor-record, deviation, tracking and reporting procedures for your tissue specialists to approve.

How does AATB or EBAA accreditation relate to FDA CGTP compliance?

They sit on top of it. AATB accredits tissue establishments and EBAA accredits entities that perform eye banking functions, while Part 1271 is federal regulation. Check your state's rules and your customers' requirements before deciding.

What must change in our procedures after a merger, new site or new product?

Section 1271.21 ties registration and listing to every HCT/P the establishment manufactures, with an annual registration update each December and a listing update after a change described in 1271.25(c), so a new product or site changes what your listing and procedures must cover. A new product also needs counsel's classification against section 1271.10(a). IHS then re-maps the applicable requirements to the changed activities and drafts the revised procedures; your establishment makes any FDA filing.