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U.S. FDA Medical Device Radiographic Film 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 Radiographic Film companies with:

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