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U.S. FDA Medical Device Cast Shoe Requirements

FDA Medical Device Definition: A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.

Registrar Corp assists Cast Shoe companies with:

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