Changing Our Minds: Reforming the FDA Medical Device Reclassification Process

Spenser F. Powell


The United States Food and Drug Administration’s (FDA) initial classification decision regarding a medical device has an enormous impact on the cost and time required—both for the manufacturer and FDA—before the device may enter the market. And, of course, a medical device can do little good for patients prior to
market entry. FDA’s premarket device-review system has received substantial criticism and calls for reform from politicians, academics, manufacturers, and FDA itself. The system is widely perceived as slow, inefficient, and substantively unpredictable. At the same time, however, another important aspect of the regulatory framework for medical devices has received relatively little attention—the reclassification process. This paper explores FDA’s procedures for reclassifying medical devices after market entry and argues that the same problems apparent in the premarket period recur in the postmarket period. Namely, FDA has used its reclassification authority in an infrequent, untimely, and unpredictable manner. This paper proposes various reforms designed to solve these problems and make reclassification a meaningful part of the federal regulatory framework for medical devices, rather than an administrative afterthought. By reviewing approved devices for reclassification on a regular timetable, adopting a clear standard for reclassification, increasing reliance on independent expert panels, and exhibiting greater flexibility in rescinding faulty decisions, FDA can make device reclassification more consistent, more accurate, and more efficient. These reforms will also allow FDA to shift time and money from premarket review to postmarket surveillance, thus permitting innovative new devices to reach consumers at a faster rate.

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