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.
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.
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