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U.S. Department of Health and Human Services

For Industry

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How do I register my HCT/P establishment?

FDA regulations (21 CFR 1271) require establishments that perform one or more steps in the manufacture of HCT/Ps to register and list their products with the agency. If you are a manufacturer that is required to register, you must do so within 5 days after beginning operations. Registrations must be updated annually in December, except as required by regulations (21 CFR 1271.26).

Registrants use Form FDA-3356, Establishment Registration and Listing for HCT/Ps, to submit HCT/P establishment registration and listing information to FDA. The form can be submitted electronically, (Electronic Human Cell and Tissue Establishment Registration (eHCTERs). Instructions for Completing the Electronic Human Cell and Tissue Establishment Registration Form are located on our website. These instructions also include information on how to edit your establishment registration information.

Form FDA-3356 (and accompanying instructions) may also be downloaded to complete and submit by mail. The Tissue Establishment Registration page provides access to the establishment registration form (Form FDA 3356), instructions for completing (paper and electronic form), and other information.

Additional HCT/P registration questions you may have may be addressed in our Establishment Registration and Listing for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) Questions and Answers.

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