by Brian Malkin
On January 26, FDA's Acting Chief Counsel, Elizabeth H. Dickinson, Esq., and FDA's Deputy Center Director for Policy, Center for Devices and Radiological Health ("CDRH"), Nancy K. Stade, Esq., spoke at the Annual Meeting of the Food, Drug and Cosmetic Law Section of the New York State Bar Association. Dickinson provided an overview of the year's hot legal issues and Stade offered her views on FDA's efforts for improving its medical review process and plans for the future.
Stade spoke first in a spirited debate between former FDA and current consultant Philip J. Phillips, Esq., President, Phillips Consulting Group, LLC, Professor Ralph F. Hall, Professor of Practice, University of Minnesota Law School, and Partner, Lauren R. Silvis, Esq., Sidley Austin LLP. Section 513 of the Food, Drug, and Cosmetic Act ("FD&C Act") mandates that, prior to marketing, FDA must classify all medical devices into one of three classes depending on the intended use, indications for use, and level of control necessary to ensure the safety and effectiveness of the device. Class I requires the least control, followed by class II, and class III requires the most control. Section 513(i) of the FD&C Act essentially states that if a new device is substantially equivalent to an already-marketed device or "predicate" device, the new device is given the same classification as the device already in the market and may be submitted as a "510(k)" submission, which is based on section 510(k) of the FD&C Act. If the new device is not substantially equivalent to any such device, the new device is placed in class III and requires a premarket approval application ("PMA") under Section 515 of the FD&C Act.
Over the years, the 510(k) process has become the most common and controversial pathway for bringing medical devices to market. FDA's definition of medical device includes products ranging from simple tongue depressors to pacemakers to laser surgical devices. Under the current 510(k) process, device manufacturers must notify FDA of their intent to market a medical device at least 90 days prior to launch. If FDA determines that the device is substantially equivalent to an existing 510(k) cleared device or other device that was on the market when the Medical Device Amendments were enacted in 1976, then it may proceed to market. If not, it must undergo pre-market approval as a premarket approval application ("PMA").