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U.S. FDA Medical Device Two-Point Discriminator Requirements


FDA Medical Device Definition: A two-point discriminator is a device with points used for testing a patient's touch discrimination.

Registrar Corp assists Two-Point Discriminator companies with:

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