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Establishment Registration Overview — 21 CFR Part 807

US-unique

Annual establishment registration with FDA is a US-specific requirement. Foreign manufacturers exporting to the USA must register their overseas facilities with FDA — there is no equivalent in most other jurisdictions.

Who must register?​

Under 21 CFR Part 807, the following must register with FDA:

  • Domestic manufacturers of finished medical devices
  • Foreign manufacturers of finished medical devices exported to the USA
  • Repackagers and relabellers (treated as manufacturers)
  • Initial importers (entities who import devices for commercial distribution)
  • Specification developers (entities that design devices but contract out manufacturing)

When to register​

  • Initial registration — before beginning commercial distribution (or importing) in the USA
  • Annual renewal — between October 1 and December 31 of each year (registration expires December 31 annually)
  • Updates — within 30 days of changes to ownership, official correspondent, or US agent

How to register​

Registration is completed through FURLS (FDA Unified Registration and Listing System):

  1. Go to FDA's device registration portal
  2. Create or log in to your FURLS account
  3. Complete establishment information and pay the annual registration fee
  4. Receive your FEI (FDA Establishment Identifier) number

Annual registration fee​

FDA charges an annual registration fee (set under MDUFA). For FY2026 the standard fee is approximately $7,653. Small businesses may qualify for reduced fees.

Official resources​

The FEI (FDA Establishment Identifier) is a unique 10-digit number assigned to your registered establishment. It is required on: all premarket submissions (510(k), PMA, De Novo), device listings (GUDID), adverse event reports (MDR), and correspondence with FDA. Maintain this number permanently as it is the master identifier for your establishment across all FDA systems and regulatory databases.