U.S. FDA Medical Device Haidinger Brush Requirements
FDA Medical Device Definition: A Haidinger brush is an AC-powered device that provides two conical brushlike images with apexes touching which are viewed by the patient through a Nicol prism and intended to evaluate visual function. It may include a component for measuring macular integrity.
FDA Haidinger Brush Label Requirements and Exceptions
FDA Haidinger Brush Import Information
FDA Haidinger Brush Detentions (Haidinger Brush Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Haidinger Brush Manufacturers (Haidinger Brush Suppliers)
- Haidinger Brush Distributors
- Haidinger Brush Processors
- Haidinger Brush Repackers
- Haidinger Brush Relabelers
- Haidinger Brush Exporters
- Haidinger Brush Importers
For more information about Haidinger Brush 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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