Scientific basis for contact lens accessory downclassification questioned by ex-FDAer Charles Kyper.
This article was originally published in The Gray Sheet
Executive Summary
CONTACT LENS ACCESSORIES DOWNCLASSIFICATION PROPOSAL: SCIENTIFIC BASIS QUESTIONED by Charles Kyper, former director of reclassification and compliance in the Office of Device Evaluation, Center for Devices and Radiological Health, in April 20 comments to FDA. The agency's proposed rule to reclassify contact lens accessories, published in the April 1 Federal Register ("The Gray Sheet" April 8, In Brief), "neither summarizes, nor provides a bibliography of, the supporting safety and effectiveness information thereby not providing an opportunity for interested persons to support, or challenge, the proposed reclassification on the sufficiency of this supporting information," Kyper says. Kyper became a consultant at C.L. McIntosh when he left FDA in August 1994, and now heads up the consulting firm Kyper & Associates.