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.
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.
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