On January 19, 2001, the Food and Drug Administration published a 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 Parts 1271, became effective on April 4, 2001 for human tissues intended for transplantation that are regulated under section 361 of the PHS Act and part 1270. It will become effective for all other HCT/Ps when the remaining parts of 21 CFR Part 1271 are finalized.

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 (electronic submission announcement).

Electronic Submission of Human Cell and Tissue Establishment Registration

Failure to Register Notice

Electronic Form Instructions

*New - Search for information on registered Human Cell and Tissue Establishments.
    Human Cell and Tissue Establishment Registration (HCTERS) Public Query Application.

Form 3356 and instructions for Establishment Registration and Listing for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) - Registered Establishments

FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Interim Final Rule; Correction - 1/30/2004 - (PDF), (Text)

• FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Interim Final Rule; Opportunity for Public Comment - 1/23/2004 - (PDF), (Text)

• FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final rule; delay of effective date - 1/21/2003 - (PDF), (Text)

• FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final Rule - 1/19/2001- (PDF), (Text)
• Q and A's Concerning Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)