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U.S. FDA Medical Device Artificial Eye Requirements

FDA Medical Device Definition: An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.

Registrar Corp assists Artificial Eye companies with:

  • FDA Artificial Eye Establishment Registration
  • FDA Artificial Eye Listing
  • FDA Artificial Eye Label Requirements and Exceptions
  • FDA Artificial Eye Import Information
  • FDA Artificial Eye Detentions (Artificial Eye Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Artificial Eye Manufacturers (Artificial Eye Suppliers)
       - Artificial Eye Distributors
       - Artificial Eye Processors
       - Artificial Eye Repackers
       - Artificial Eye Relabelers
       - Artificial Eye Exporters
       - Artificial Eye Importers
For more information about Artificial Eye Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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