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U.S. FDA Medical Device Nasal Dilator Requirements

FDA Medical Device Definition: A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.

Registrar Corp assists Nasal Dilator companies with:

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