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AbstractRegulatory sandboxes have become the latest development in regulatory reform, starting first in financial regulation and now expanding to other sectors. While sandboxes offer notable potential benefits for managing emerging technologies, achieving desirable policy outcomes with this novel regulatory instrument also comes with technical and political challenges. This article offers a framework to characterize regulatory sandboxes in any sector, involving a blend of (1) approval regulation with broad‐based standards, (2) restricted discretion by the regulator for specific norms, (3) process‐oriented regulation, (4) an outcomes‐orientation, and (5) structured regulator–regulatee information sharing or dialogue. Using this model, the article outlines issues in compliance and legitimacy, including in trust and accountability, responsive enforcement, the politics of participation, and post‐sandbox oversight. The article concludes by calling for greater scrutiny when considering implementing a sandbox instrument, with attention to sector‐specific concerns, and offering directions for empirical evaluation of regulatory sandboxes.

The COVID-19 epidemic has been exacerbated by failures in diagnostic testing for the virus in the United States. In response to these problems, two bills have been introduced in Congress to not only reform emergency use of diagnostic tests, but to fundamentally reform diagnostics regulation in non-emergencies. There has been a long-standing recognition that current U.S. regulation of diagnostics is outdated and problematic, and the history of public health legislation is that emergencies and crises have been the primary motivating factor to break Congressional inertia and to implement new legislation. Thus, the COVID-19 may create a useful "window of opportunity" to pass much-needed legislative reform of diagnostic regulation in both emergency and non-emergency contexts. At the same time, rushing radical legislative changes, especially if they have not been subject to careful stakeholder engagement and Congressional deliberation in advance, is precarious and could result in reckless and disruptive changes. We review and apply the historical lessons of legislating in response to a crisis and conclude the one but not both of the pending legislative proposals may satisfy the criteria for an appropriate opportunistic change for diagnostics regulation.