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U.S. FDA Medical Device Face Plate 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 Face Plate Hearing Aid companies with:

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