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U.S. FDA Medical Device Powered Communication System Requirements


FDA Medical Device Definition: A powered communication system is an AC- or battery-powered device intended for medical purposes that is used to transmit or receive information. It is used by persons unable to use normal communication methods because of physical impairment. Examples of powered communication systems include the following: a specialized typewriter, a reading machine, and a video picture and word screen.

Registrar Corp assists Powered Communication System companies with:

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