FDA to Begin Inactivating Out-of-Date HCT/P Facility Registrations

The Food and Drug Administration will begin inactivating the registrations of establishments that manufacture human cells, tissues, or cellular or tissue-based products (HCT/Ps) that have not updated their registration in the electronic human cell and tissue establishment registration system (eHCTERS).

Federal regulations require establishments that manufacture 361 HCT/Ps to register and list their HCT/Ps with FDA's Center for Biologics Evaluation and Research within five days of beginning operations. Additionally, facilities must update their registration during an annual update period (Nov. 15 – Dec. 31) and within 30 days of certain changes.

In the announcement, FDA noted that in recent years, 390 of 2,671; 379 of 2,361; and 319 of 2,431 registered domestic and foreign HCT/P establishments failed to submit annual registrations for 2019, 2020 and 2021, respectively. The agency emphasized that outdated or otherwise unreliable information compromises the integrity of the HCT/P registration and listing database, which is critical to FDA’s mission to protect the public health by reacting swiftly to newly discovered or understood risks by enabling FDA to quickly alert industry of concerns and effectively monitor compliance under FDA's risk-based surveillance inspection program.

Beginning Aug. 30, 90 days after publication of the Federal Register notice, and continuing every January thereafter, FDA will inactivate an HCT/P establishment's registration if the establishment fails to submit the annual registration during the update period. Furthermore, FDA will no longer attempt to follow up with establishments to rectify their registration status.

The eHCTERS public query application will display the establishment registration status as “inactive” and include the last annual registration year. If an establishment changes or updates its registration in eHCTERS after its registration inactivates, the eHCTERS public query application will display the establishment's status as “registered” and the last annual registration year will update to the current year.

Facilities with questions may contact tissuereg@fda.hhs.gov.