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U.S. FDA Medical Device ENT Applicator 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 ENT Applicator companies with:

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