Medical Devices; Reclassification and Codification of the Daily Wear Soft and Daily Wear Nonhydrophilic Plastic Contact Lenses

摘要

The Food and Drug Administration (FDA) is codifying the reclassification of daily wear soft and daily wear nonhydrophilic plastic contact lenses from class III (premarket approval) into class II (special controls). Elsewhere in this issue of the Federal Register FDA has issued an order of reclassification as 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, elsewhere in this issue of the Federal Register, in conjunction with the order reclassifying the devices, FDA is announcing the availability of a guidance document describing those safeguards in the form of evidence needed to demonstrate the substantial equivalence of new daily wear soft and daily wear nonhydrophilic contact lenses to lenses already marketed.