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U.S. FDA Medical Device Spectacle Frame Requirements

FDA Medical Device Definition: A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.

Registrar Corp assists Spectacle Frame companies with:

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