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U.S. FDA Medical Device Air Conduction Hearing Aid Requirements


FDA Medical Device Definition: A hearing aid is wearable sound-amplifying device that is intended to compensate for impaired hearing. This generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400)

Registrar Corp assists Air Conduction Hearing Aid companies with:

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