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U.S. FDA Medical Device Vision Aid Requirements

FDA Medical Device Definition: An electronic vision aid is an AC-powered or battery-powered device that consists of an electronic sensor/transducer intended for use by a patient who has impaired vision or blindness to translate visual images of objects into tactile or auditory signals

Registrar Corp assists Vision Aid companies with:

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