Facilities that handle human cells, tissues, and cellular and tissue-based products, generally referred to as HCT/Ps, are required to register with FDA and list the products they handle. Request current registration and applicable licensure documentation for qualified-buyer verification. The requirement applies across a range of establishment types, from tissue banks to distributors that store or ship product on a facility's behalf.
Registration does not establish product approval. Review the specific product's regulatory documentation. A registration number on its own says only that a facility told FDA what it does. It does not establish that a given product meets the applicable criteria in 21 CFR 1271.10, or that any marketing claim made about it is accurate.
For a clinic evaluating a supplier, registration status is one data point among several. Useful follow-up questions include which specific activities a facility is registered for, whether a distributor is relying on a manufacturer's registration or holds its own, and whether current registration and listing documentation can be produced on request. Pairing that with sterility testing records and a certificate of analysis gives a more complete picture than registration status alone.
Clinics asked to verify a supplier's regulatory standing should treat establishment registration as a baseline filing to confirm, not as proof that a product is safe, effective, or appropriate for a given use.