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

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