US FDA's device approval process

Connecting Expertise to Government

Active

Since 2015

The GovLab, MetroTech Center, Brooklyn, NY, USA

The Governance Lab @ NYU and MacArthur Foundation Research Network on Opening Governance are evaluating several potential impacts of the introduction of a piece of expert networking software, FDA Profiles to the review process. This software is designed to decrease frictions in identifying qualified government employees to participate in medical device regulatory review panels. FDA Profiles aggregates information about the expertise of potential reviewers including historical project roles from the FDA's internal HR database, publications on PubMed, and self-reported information about an individual's skills and experience. The introduction of FDA Profiles will seek to accomplish two goals: 1) Understanding drivers of the efficiency and effectiveness of the regulatory review process for new medical products is of great interest for policy makers. As such, a better understanding of tools – such as digital platforms – that may improve the process of regulatory review will be relevant to managers in multiple government agencies. 2) Testing a new methodology for devising and implementing real-world, empirical, agile experimentation with a governing partner will uncover new opportunities for incorporating evidence-based decision-making into governance.