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U.S. FDA Medical Device Silicone Elastomer Requirements


FDA Medical Device Definition: Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

Registrar Corp assists Silicone Elastomer companies with:

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