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U.S. FDA Medical Device Magnifying Spectacle Requirements

FDA Medical Device Definition: Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.

Registrar Corp assists Magnifying Spectacle companies with:

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