Medical Devices; Reclassification of the Daily Wear Soft and Daily Wear Nonhydrophilic Plastic Contact Lenses; Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses; Availability

Summary

The FDA is reclassifying daily wear soft and daily wear nonhydrophilic plastic contact lenses from class III to class II, requiring a premarket notification (510(k)) for new devices, and announcing the availability of a guidance document to demonstrate substantial equivalence.