Institutional Mediation of Medical Device Innovation: The Role of Regulatory Capability in FDA 510(k) Review Duration

Medical device innovation depends not only on technological development but also on institutional review processes that determine when new or modified devices can enter the market. This study examines the role of review route choices and accumulated regulatory experience in shaping the duration of FDA 510(k) reviews. Using 97,623 submissions from 22,838 firms over 1995–2025, this study models FDA 510(k) review duration across review channels and pathways while accounting for the nonrandom use of third-party review. The results show that third-party review is strongly associated with shorter review durations, both after selection adjustments and within Traditional 510(k) submissions. Special 510(k)s also clear faster, while Abbreviated submissions show limited timing advantages unless paired with third-party review. Prior FDA and product-space experience are also associated with faster clearance, suggesting that regulatory capability influences the institutional timing through which medical device innovation moves from development to market availability. The findings highlight the importance of regulatory execution within the broader innovation process in approval-mediated industries.