The FDA’s Center for Devices and Radiological Health (CDRH) manages the process of pre- market approval of all medical devices. Finding and convening a qualified regulatory review panel to assess the safety and effectiveness of a new product can take as long as nine months. Because the FDA has seen a rapid increase in new medical devices being developed and submitted for regulatory approval, improving the efficiency of regulatory review without compromising its effectiveness is a highly desirable policy goal.
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.
Access to the software will be rolled out to employees of the FDA’s Center for Devices and Radiological Health (CDRH) in a staggered fashion over a six-month period. Researchers from the GovLab and Network will evaluate the impact of CDRH employee access to FDA Profiles on the composition of review panels, the time needed for a panel to be convened, the time required for a panel to review a new medical device, and subsequent safety data for products reviewed – for example, product recalls and reported adverse events following regulatory approval.