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U.S. FDA Medical Device Sunglasses Requirements

FDA Medical Device Definition: Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

Registrar Corp assists Sunglasses companies with:

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