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U.S. FDA Medical Device External Adhesive Prosthesis Requirements


FDA Medical Device Definition: An external prosthesis adhesive is a silicone-type adhesive intended to be used to fasten to the body an external aesthetic restoration prosthesis, such as an artificial nose.

Registrar Corp assists External Adhesive Prosthesis companies with:

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