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U.S. FDA Medical Device Joint Ring Requirements

FDA Medical Device Definition: A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

Registrar Corp assists Joint Ring companies with:

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