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U.S. FDA Medical Device Anti-Stammering Device Requirements


FDA Medical Device Definition: An antistammering device is a device that electronically generates a noise when activated or when it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech.

Registrar Corp assists Anti-Stammering Device companies with:

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