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U.S. FDA Medical Device Permanent Magnet Requirements


FDA Medical Device Definition: A permanent magnet is a nonelectric device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.

Registrar Corp assists Permanent Magnet companies with:

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