In 2009 the FDA requested the Institute of Medicine (“IOM”), a part of the National Academy of Sciences, to undertake a study of its 510(k) approval process to determine its effectiveness and to make recommendations to improve and strengthen it. It hardly imagined that the recommendation out last week would be to dump it altogether. The 510(k) clearance process for moderate risk devices such as hip replacement devices, external heart defibrillators and hospital based pumping devices provides an easier road for medical device manufacturer’s to obtain regulatory approval of new technological advances in medical devices without going through the more cumbersome, comprehensive and expensive PMA or premarket approval process required for higher risk products.
In order to qualify for the 510(k) approval process a manufacturer must establish that a product is “substantially equivalent” to a product currently on the market. This is a “piggy backing” process without an independent examination of product safety. The IOM came to the conclusion that the 510(k) process cannot be transformed into a reliable pre-market and post market screen for the safety and effectiveness of Class II (moderate risk) devices. The IOM determined that the FDA lacks a statutory basis to achieve an integrated premarket and post market regulatory framework designed to effectively protect public safety.
The IOM recommended further that the FDA speed up the process of review as to what devices should be included in Class III (high risk) categories. It encourages the FDA to base its decisions on “sound science,” with a process that is “clear, predictable, straight forward and fair.” It stresses the need for constantly self sustaining and self improving designs and the need to facilitate innovation. Interestingly, it also calls upon the FDA to develop a greater understanding of the role of software in medical devices and its interplay with hardware as that seems to be a major deficit in the approval process.
The Advance Medical Technology Association, the medical device equivalent of Pharmaceutical Research and Manufacturers of America (PhRMA), has already mounted and offensive against the IOM recommendation as has the industry friendly Washington Legal Foundation, which filed a suit last month to obtain a ruling that the FDA is statutorily barred from accepting the IOM recommendations because of the lack of industry officials, investors and patients on the IOM panel.
As Kurt Vonnegut remarked, “[s]o it goes.”