Establishment Registration

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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:

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• Contract manufacturers

• Contract sterilizers

• Initial Importers

• Relabeler or Repackager

• Remanufacturer

• Specification Developer

• Foreign Exporters

• Foreign Manufacturers

• Re-processors of Single-use Devices

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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.

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Device Registration

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