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U.S. FDA Medical Device Cast Component Requirements

FDA Medical Device Definition: A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.

Registrar Corp assists Cast Component companies with:

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