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U.S. FDA Medical Device Amsler Grid Requirements

FDA Medical Device Definition: An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.

Registrar Corp assists Amsler Grid companies with:

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