SPECIAL CONTROLS IDENTIFICATION IN 515(i) DOWNCLASSIFICATION REQUESTS WILL EXPEDITE FDA ACTION, LEVITT SAYS; ODE TO MONITOR PROGRAM'S RESOURCE DEMANDS
This article was originally published in The Gray Sheet
Executive Summary
Manufacturers should take the lead in identifying and developing special controls as part of downclassification requests under Sec. 515(i) of the Food, Drug and Cosmetic Act rather than leaving the work to FDA, Joseph Levitt, deputy director for regulations and policy in FDA's Center for Devices and Radiological Health, said at a June 7 workshop in Arlington, Virginia.