Vaccines, Blood & Biologics

Tissue Establishment Registration

On January 19, 2001, the Food and Drug Administration published a registration and listing final rule that requires human cells, tissue, and cellular and tissue-based product establishments to register with the agency and list their human cells, tissues, and cellular and tissue-based products (HCT/Ps). The final rule, 21 CFR Part 1271, became effective on April 4, 2001 for human tissues intended for transplantation that are regulated under section 361 of the PHS Act and 21 CFR Part 1270. The final rule became effective on March 29, 2004 for all other HCT/Ps except that registration and listing requirements related to human dura mater and heart valves became effective when the remaining parts of 21 CFR Part 1271 were implemented on May 25, 2005.

As explained in 1271.21, establishments covered by the final rule must register within 5 days after beginning operations. An annual update is required in December and changes in HCT/P listing within 6 months of the change. If the ownership or location of the establishment changes, an amendment to the establishment registration must be submitted within 5 days of the change.

To facilitate establishment registration and listing, FDA has developed Form FDA 3356 (Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)) and instructions for completion that may be used to submit electronically or in paper form by mail or FAX.

Form FDA-3356 is now accepted by electronic submission through a secure web server.

Search for Information on Registered Human Cell and Tissue Establishments

Page Last Updated: 12/11/2014
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