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.
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.
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