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U.S. FDA Medical Device Therapeutic Medical Binder Requirements


FDA Medical Device Definition: A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder.

Registrar Corp assists Therapeutic Medical Binder companies with:

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