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In Brief: Contact lens accessory downclassification

This article was originally published in The Gray Sheet

Executive Summary

Contact lens accessory downclassification: Effective July 7, FDA reclassifies rigid gas permeable contact lens solutions, hydrophilic contact lens solutions and contact lens heat disinfecting units from Class III to Class II in a final rule published in the June 6 Federal Register. FDA 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. The agency asks sponsors to review their applications and advise FDA on the type of administrative action that should be taken. In a separate June 6 Federal Register notice, FDA announces availability of a guidance 510(k) for the lens care products ("The Gray Sheet" June 2, p. 10.)...

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