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U.S. FDA Medical Device Breast 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 Breast Binder companies with:

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