REGULATORY UPDATE: AABB Releases New FDA eHCTERS Toolkit

The AABB Regulatory Affairs Committee has released a new regulatory toolkit designed to support FDA establishment registration and product listing through the electronic human cells, tissues, and cellular and tissue‑based products (HCT/P) establishment registration and listing system (eHCTERS).

This toolkit is intended for establishments that manufacture HCT/Ps in accordance with 21 CFR Part 1271, the Public Health Service (PHS) Act, and the Federal Food, Drug and Cosmetic Act.

Under 21 CFR Part 1271 and the PHS Act, establishments manufacturing HCT/Ps regulated solely under section 361 of the PHS Act are required to register with FDA and list their HCT/Ps both initially and on an annual basis. These requirements apply to establishments performing activities such as recovery, processing, storage, labeling, packaging, distribution, and donor screening and testing. Covered products include those intended for implantation, transplantation, infusion, or transfer into a human recipient. Applicable exemptions from registration and listing are outlined in 21 CFR 1271.15.

The toolkit is limited to 361 HCT/Ps, as defined in 21 CFR 1271.10, and does not address products regulated as biological drugs under section 351 of the PHS Act. Its primary focus is to provide practical, step‑by‑step regulatory support for completing FDA registration and product listing using eHCTERS, including clarification of common registration elements, terminology and submission expectations. The toolkit also notes that establishments may request a waiver from electronic submission in accordance with 21 CFR 1271.23, when appropriate.