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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Electronic Human Cell and Tissue Establishment Registration (eHCTERS)

Form FDA-3356 (Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)) is now being accepted by electronic submission through a secure web server.

All establishments that manufacture HCT/Ps are required to register with the FDA, pursuant to 21 CFR Part 1271. They must register within 5 days of beginning operation, and annually in December. Registrants must also submit a list of every HCT/P manufactured, and update their HCT/P listing every June and December if there is a change.

HCT/P establishments located outside of the United States that import or offer for import HCT/Ps into the U.S. are required to register with FDA. Foreign registrants must provide the name of their United States agent, the name of each importer and each person who imports or offers for import the registrant's HCT/Ps.

Registrants use Form FDA-3356, Establishment Registration and Listing for HCT/Ps, to submit registration and HCT/P listing information to us. The form (and accompanying instructions) may be downloaded to complete and submit by mail. Alternatively, the form can now be submitted electronically (Electronic Human Cell and Tissue Establishment Registration (eHCTERs)