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U.S. FDA Medical Device Prescription 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 Prescription Spectacle Lens companies with:

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