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U.S. FDA Medical Device Manual Perimeter Requirements

FDA Medical Device Definition: A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

Registrar Corp assists Manual Perimeter companies with:

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