Abstract 17089: The Impact of the Food and Drug Administration’s Priority Review Pathway on Breakthrough Cardiovascular Devices
Background: The FDA requires pre-market approval (PMA) review of clinical trial data to ensure the safety and effectiveness of high-risk medical devices. Priority PMA review is an alternative pathway intended for innovative and life-saving devices to speed their time to market. To better understand the differences in these pathways, we compared the time to approval and recall rates of devices undergoing priority and standard PMA review for cardiovascular devices and all other devices.
Methods: All original high-risk medical devices receiving PMAs between January 1, 2005 and December 31, 2015 were identified using FDA-maintained databases. Each PMA was abstracted for data on device type, review pathway and approval date. We then determined the recalls and adverse events associated with each device using the FDA’s Medical Device Recall and MedSun databases.
Results: Between 2005 and 2015, the FDA approved 230 devices by original PMA review; 29 of the 230 devices were approved via priority review. Cardiovascular devices comprised 12 of the 29 priority approvals (41%). While the mean approval time for priority review devices overall was 25.3 months compared to 18.2 months for standard review, the mean time for priority-reviewed cardiovascular devices was 20.7 months and was even shorter for standard review cardiovascular devices (14 months). Overall, 55% of priority review devices were subject to recall action in an average follow-up of 5 years, compared with only 22% of standard review devices (average follow-up 5.2 years). There was also a shorter mean time from approval to first recall event for priority review devices (20.3 months) compared to standard review devices (31.1 months).
Conclusions: Cardiovascular devices make up the largest category of devices receiving PMAs and have shorter priority and standard review times than other devices. Overall, high-risk medical devices approved by priority review, including cardiovascular devices, undergo longer PMA review times and are associated with more recall events. This may reflect the novel technologies of the devices under review. Further work is needed to ensure that the priority PMA pathway is meeting its goal of delivering safe, effective, and timely access to breakthrough devices.
Author Disclosures: C. Ong: None. R. Redberg: None.
- © 2016 by American Heart Association, Inc.