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U.S. FDA Medical Device Reusable Image Media Requirements


FDA Medical Device Definition: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.

Registrar Corp assists Reusable Image Media companies with:

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