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

Resumo

The Food and Drug Administration (FDA) is issuing an order reclassifying daily wear soft and daily wear nonhydrophilic plastic contact lenses from class III (premarket approval) into class II (special controls). This reclassification is required by the Safe Medical Devices Act of 1990 (the SMDA). This reclassification only applies to daily wear soft and daily wear nonhydrophilic contact lenses. Lenses intended for extended wear will remain in class III, as will contact lens accessories. The SMDA also requires FDA to put into place any regulatory safeguards that are necessary to provide reasonable assurance of the safety and effectiveness of the reclassified lenses. Thus, FDA is announcing the availability of a guidance document entitled ``Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses.'' The guidance sets forth the evidence that should be submitted to FDA to demonstrate the substantial equivalence of new daily wear soft and daily wear nonhydrophilic plastic contact lenses to lenses already marketed. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to codify the reclassification of the daily wear contact lens from class