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  1. Biologics Establishment Registration

Tissue Establishment Registration

Establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service (PHS) Act are required to register with FDA pursuant to 21 CFR Part 1271. Establishments must register and list their HCT/Ps within 5 days of beginning operation and registration must be updated annually in December.

HCT/P establishments located outside of the United States (U.S.) that import, or offer for import, HCT/Ps into the U.S. are required to register with FDA. Foreign registrants must provide the name of their U.S. agent(s), the name of each importer, and each person who imports or offers for import the registrant's HCT/Ps. Other requirements for a foreign establishment’s registration and listing are described in §1271.25.

If the ownership or location of an HCT/P establishment changes, or if there is a change in the U.S. agent's name, address, telephone number, or email address, an amendment to registration must be submitted within 30 calendar days of the change. Establishments must amend their HCT/P listing if a change described in §1271.25(c)(1) through (4) has occurred. Such new information must be submitted at the time of change, or each June or December, whichever month occurs first.

FDA published in the Federal Register of August 31, 2016 (81 FR60170) a final rule that amended FDA’s regulations governing drug establishment registration and drug listing, including establishment registration and listing for HCT/Ps. Electronic submission of HCT/P establishment and product listing information is now required under §1271.22, unless waived in certain circumstances.  HCT/P establishments that must register and list electronically under 21 CFR Part 1271 should use the electronic HCT/P establishment registration (eHCTERS) system to meet the requirement for electronic submission of establishment registration and product listing. Establishments may request a waiver from the electronic submission requirement as described in §1271.23.

Note: Under the August 31, 2016 final rule, manufacturers of HCT/Ps that are regulated as drugs, devices, and/or biological products under section 351 of the PHS Act or under the Food, Drug, and Cosmetic Act, must register and list their products in accordance with 21 CFR Part 207 or 807, as applicable, rather than 21 CFR Part 1271.

Note: FDA does not require establishments that manufacture drugs (including biological products) and devices that are HCT/Ps for use under an investigational new drug application (IND) (21 CFR Part 312) or an investigational device exemption (IDE) (21 CFR Part 812) to register and list their HCT/Ps until the HCT/P is approved through a biologics license application (BLA), new drug application (NDA), or premarket approval application (PMA); or cleared through a premarket notification submission (510(k)).

Access to eHCTERS via CBER On-Line

Instructions and Background Information

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