FDA Medical Device Definition: A cast cover is a device intended for medical purposes that is made of waterproof material and placed over a cast to protect it from getting wet during a shower or a bath.
Registrar Corp assists Cast Cover companies with:
FDA Cast Cover Establishment Registration
FDA Cast Cover Listing
FDA Cast Cover Label Requirements and Exceptions
FDA Cast Cover Import Information
FDA Cast Cover Detentions (Cast Cover Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Cast Cover Manufacturers (Cast Cover Suppliers)
- Cast Cover Distributors
- Cast Cover Processors
- Cast Cover Repackers
- Cast Cover Relabelers
- Cast Cover Exporters
- Cast Cover Importers
For more information about Cast Cover 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.