Contact lens care products' downclassification questioned by former FDAer.
This article was originally published in The Tan Sheet
Executive Summary
CONTACT LENS CARE PRODUCTS' PROPOSED DOWNCLASSIFICATION BY FDA is questioned by former FDAer Charles Kyper in recent comments to the agency. Kyper argues that FDA's proposed rule to reclassify contact lens accessories "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."