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U.S. FDA Medical Device Eye Pad Requirements

FDA Medical Device Definition: An eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions.

Registrar Corp assists Eye Pad companies with:

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