IP and FDA Regulation of De Novo Medical Devices

Attempts to modernize and speed up the FDA’s premarketing clearance and classification process for medical devices have included both new device classifications and ways of filing abbreviated applications. The FDA’s “De Novo” classification and Breakthrough Devices program allow applicants to create entirely new medical device types, with special controls and technological characteristics, including specifications on hardware and software. To encourage innovation and competition, the 21st Century Cures Act allows De Novo devices to serve as “predicates” for subsequent follow-on medical devices through the 510(k) application process, if such follow-on devices use the same controls and possess “the same” technological characteristics as the “predicate” device. This lends itself to a potentially anticompetitive strategy mediated by the interaction between IP and the 510(k) application requirements: successful De Novo applicants could use their portfolios to prevent follow-on applicants from making use of similar characteristics – potentially stymying an entire class of follow-on devices in the process. This strategy could threaten a greater diversity of new devices; may encourage an “up” classification of devices; and incentivizes technical characteristics and special controls of De Novo devices where general ones may suffice. This chapter concludes by proposing future evidence-based research in the area.