Which establishments that manufacture HCT/Ps need to register and list?
- If you are an establishment that manufactures HCT/Ps that are regulated solely under section 361 of the PHS Act and the regulations in part 1270, you were required to register and list under 21 CFR Part 1271 in 2001.
- If you are an establishment that manufactures HCT/Ps that are:
- Medical Devices;
- Biological Products
- Hematopoietic stem cells from peripheral and cord blood;
- Reproductive cells and tissues; and
- Human heart valves and human dura mater,
you are required to register with FDA and list your HCT/Ps using the registration and listing procedures in 21 CFR part 1271, subpart B.
HCT/P establishments that only manufacture HCT/Ps currently under IND or IDE do not need to register and list their HCT/Ps until the investigational HCT/P is approved through a Biologics License Application (BLA), a New Drug Application (NDA), or a Premarket Approval Application (PMA); or cleared through a Premarket Notification Submission (510(k)).
Which establishments are exempt from HCT/P registration and listing?
If an establishment qualifies for any of the exceptions listed in 21 CFR 1271.15, the establishment does not have to register and list their HCT/Ps with CBER.
After initial registration, will HCT/P establishments have to register again?
Establishments must update their registration annually in December and submit changes in HCT/P listing within 6 months of the change (21 CFR 1271.21). Even if there are no changes or updates to an establishment's HCT/P listing, the establishment must still register annually. We recommend that establishments keep a record on file containing the field establishment identifier number (FEI #) and validation date of the registration as this information is necessary to make changes and updates electronically. If the ownership or location of the establishment changes, the establishment must submit an amended registration form within 5 days of the change (21 CFR 1271.26).
What would happen if an establishment does not register or forgets to send in the annual registration?
If an establishment fails to register or does not submit annual registration, the establishment is considered to be in violation of the regulations.
How will an establishment know when it is registered with FDA?
After FDA processes the establishment's registration form, FDA will send to the Reporting Official a validated form, which includes the registration number (FEI #). If the establishment already registered under 21 CFR Parts 207, 607, or 807, the establishment will retain the same FEI #. If the establishment needs to know its registration status prior to receiving its validated form, the establishment may contact FDA at email@example.com or access the Public Query application to determine if FDA has classified the establishment as "pre-registered." The classification will change to "registered" when the FEI # has been generated. However, FDA considers the establishment to be registered as soon as FDA receives the Form FDA 3356. Conversely, the same applies when an establishment updates the registration Form FDA 3356 from "registered" to "inactive." An establishment may also use the Public Query to access a list of other establishments that are registered with the FDA.