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U.S. FDA Medical Device Ear Wick Requirements

FDA Medical Device Definition: An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

Registrar Corp assists Ear Wick companies with:

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