U.S. FDA Medical Device Spectacle Lens Requirements
FDA Medical Device Definition: A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.
FDA Spectacle Lens Label Requirements and Exceptions
FDA Spectacle Lens Import Information
FDA Spectacle Lens Detentions (Spectacle Lens Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Spectacle Lens Manufacturers (Spectacle Lens Suppliers)
- Spectacle Lens Distributors
- Spectacle Lens Processors
- Spectacle Lens Repackers
- Spectacle Lens Relabelers
- Spectacle Lens Exporters
- Spectacle Lens Importers
For more information about Spectacle Lens 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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