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U.S. FDA Medical Device Spectacle Lens Requirements

FDA Medical Device Definition: A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.

Registrar Corp assists Spectacle Lens companies with:

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