Establishment Registration

The following type of establishments:

  • Contract Manufacturer
  • Contract Sterilizer
  • Foreign Exporter
  • Initial Distributor
  • Manufacturer
  • Repackage
  • Relabelers
  • Remanufacturer
  • Preprocessors of Single Use Devices
  • Specification Developer
  • U. S. manufacturer of export only devices

involved in the production and distribution of medical devices intended for commercial distribution in the U.S.A are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices. Read More >>

If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number/510k.

The requirements for registration and listing based on the type of activity performed at that establishment. More details about which types of activities require payment of the establishment registration fee. Read More>>

Any clarification please contacts us. Our consultant will contact you at the earliest.

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