SUN-PROTECTIVE CLOTHING REGULATION AS MEDICAL DEVICE QUESTIONED
This article was originally published in The Gray Sheet
Executive Summary
SUN-PROTECTIVE CLOTHING REGULATION AS MEDICAL DEVICE QUESTIONED by Robert O'Holla, vice president of regulatory affairs at Johnson & Johnson, at a Sept. 21 meeting of FDA's General and Plastic Surgery Devices Advisory Panel. O'Holla, the industry representative to the panel, said FDA is not exercising appropriate "discretion" in choosing to regulate sun-protective clothing at a time when it lacks "the resources to handle some of our more important technological breakthroughs."