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U.S. FDA Medical Device Patient Position Support Requirements


FDA Medical Device Definition: A patient position support is a device intended to maintain the position of an anesthetized patient during surgery.

Registrar Corp assists Patient Position Support companies with:

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