For Industry

What is the status of my registration?

After an establishment's registration form is processed, FDA will send the Reporting Official a validated form, which includes the registration number (FEI #). If an establishment is already registered under 21 CFR Parts 207, 607, or 807, the establishment will retain the same FEI #.

If you need to know your registration status prior to receiving your validated form:

  • For tissue registration, access the Human Cells and Tissue Establishment Registration (HCTERS) Public Query Application to determine if FDA has classified your establishment as "pre-registered." In HCTER, the registration status will change to "Registered" when the FEI # has been generated and registration processing is completed. You may also contact FDA by email at tissuereg@fda.hhs.gov about your HCT/P registration.
  • For Blood Establishment Registration (BER), access the public query using the “Find a Blood Establishment” link on our website to determine if FDA has classified your establishment as "pre-registered." In BER, the registration status will change to "Active" when the FEI # has been generated and registration processing is completed. You may also contact FDA by email at bloodregis@fda.hhs.gov about blood registration.

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Page Last Updated: 01/16/2015
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