The negative effect doctrine discussed in this chapter deals with when, if ever, a state court will stay proceedings before it and refer disputants to the arbitrators for them to decide, in the first instance, whether an arbitration agreement between the parties (i) exists, (ii) is valid, and (iii) has a scope that covers the dispute in question. An affirmative answer on each of these points would mean that the dispute’s merits must be decided in arbitration. Thus, the negative effect issue concerns whether a decision on these three jurisdiction sub-issues should be decided with finality by the court itself at the outset, or, in the first instance, by the arbitrators themselves, with possible court review on jurisdiction delayed until later.The chapter discusses the dramatically different approaches to the negative effect issue followed in several leading arbitral jurisdictions: France, Germany, the U.S., Switzerland, the U.K., and Canada (Quebec).It also discusses the underlying policy issues at stake in the different national approaches to the doctrine.In conclusion the chapter offer’s the author’s view of a preferred approach to the negative effect issue.

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.