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U.S. FDA Medical Device Otoscope Requirements

FDA Medical Device Definition: An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.

Registrar Corp assists Otoscope companies with:

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