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U.S. FDA Medical Device Cast Bandage 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 Bandage companies with:

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