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U.S. FDA Medical Device Plinth Requirements

FDA Medical Device Definition: A plinth is a flat, padded board with legs that is intended for medical purposes. A patient is placed on the device for treatment or examination.

Registrar Corp assists Plinth companies with:

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