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Regulation

FDA Establishment Registration

FDA Establishment Registration is a mandatory FDA facility registration in which a facility provides its name, address, and activity information to the FDA. It does not measure, verify, or certify the purity, identity, or safety of any product, and it is not FDA approval.

Also called: Establishment Registration, FDA Registration

FDA Establishment Registration is a mandatory administrative filing for domestic and foreign facilities manufacturing, repacking, or re-labeling drugs and medical devices in the United States. Under Section 510 of the Federal Food, Drug, and Cosmetic Act, this registration serves as a legal record of a facility's existence but does not constitute FDA approval, proof of CGMP compliance, or a product quality claim.

Registration records facility identity and location

Facilities submit operational details, including company name, address, ownership, and specific types of activities, through the FDA Direct Portal. Once processed (up to 90 days), the FDA assigns a Facility Establishment Identifier (FEI) number to the site. This registration confirms facility identity and location rather than providing analytical testing or product verification. When a vendor cites an FDA Establishment Registration number, it simply verifies that the facility is listed in the government database. While establishment registration identifies the facility, a separate process called Drug or Device Listing also exists.

Common misinterpretations of FDA registration

  • Treating registration as FDA approval
  • Assuming CGMP compliance
  • Confusing it with 510(k) or PMA clearance
  • Mistaking it for a product listing
  • Using it as proof of manufacture at that facility
  • Viewing it as evidence of purity
  • Identity confirmation
  • Safety assurance

Sources

  1. Registration and Listing
  2. US FDA Establishment Registration and Device Listing Experts
  3. Who Must Register, List and Pay the Fee
  4. Device Registration and Listing
  5. Drug Establishments Current Registration Site (DECRS) | FDA
  6. Questions and Answers: Outsourcing Facility Registration | FDA
  7. How to search FDA registration number - FDAbasics
  8. FDA US Agent $279 | Search FDA Registration Number | Willow Glen
  9. What Is FDA Device Registration and Listing? Complete Guide
  10. Establishment Registration Quick Guide
  12. FDA Medical Device Establishment Registration | Emergo by UL
  13. WHO NEEDS TO REGISTER, LIST AND PAY FOR MEDICAL DEVICE REGISTRATION – FDA News
  14. How to Conduct FDA Number Search ? | FDA Listing Inc
  15. Drug Establishments Current Registration Site
  16. Small Entity Compliance Guide: Current Good ...
  17. Establishment Registration & Device Listing
  18. 503A vs. 503B: A Quick-Guide to Compounding Pharmacy Designations & Regulations