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.

The rise and ease of genome-editing technologies, like CRISPR, has ushered in communities of “biohackers,” do-it-yourself enthusiasts for molecular genetics who perform experiments outside traditional institutional laboratory settings. Conventional wisdom posits that such research is beyond traditional modes of regulation or legal enforcement and that new biohacking laws are needed. This view, however, is incorrect; both public and private regulators currently possess–and in other contexts, use–many of the tools needed to regulate the safety and ethics of biohacking. The U.S. Food and Drug Administration, for example, has expansive authority over “biologics,” which includes many of the biohacking kits currently in use. Patent holders and community laboratories similarly have the power to impose ethical and safety restrictions on biohacking activities. Rather than new laws or stiffer enforcement, regulators should do what they do for other industries: actively engage with the community to educate and promote the advancement of technology.