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Establishment and Device Registration

Establishment Registration

Device manufacturers are required to submit a pre-market submission and register with the FDA to market a product in the United States. Unless a device is exempt, the following entities must register with the FDA and pay the registration fee:

  • Contract manufacturers

  • Contract sterilizers

  • Initial Importers

  • Relabeler or Repackager

  • Remanufacturer

  • Specification Developer

  • Foreign Exporters

  • Foreign Manufacturers

  • Re-processors of Single-use Devices

Registration is completed electronically on the FDA website. Establishments must create an account and pay the Registration fee. Foreign establishments must select a FDA U.S. Agent during registration.

Device Registration

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