Executive Summary

Contact lens accessory downclassification: Effective July 7, FDA reclassifies rigid gas permeable contact lens solutions, hydrophilic contact lens solutions and contact lens disinfecting units from Class III to Class II in a final rule recently published in the Federal Register. The agency states that all reviews of pending premarket approval applications for the devices are suspended and will be examined to determine those that can be converted to 510(k) submissions and those that may be exempt from 510(k) requirements. FDA asks sponsors to review their applications and advise the agency on the type of administrative action that should be taken. FDA recently announced the availability of a 510(k) guidance for the lens care products ("The Tan Sheet" June 2, p. 17)...