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U.S. FDA Medical Device External Breast Prosthesis Requirements


FDA Medical Device Definition: An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.

Registrar Corp assists External Breast Prosthesis companies with:

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