Medical devices approved after receiving priority review from FDA are more likely to be recalled than high-risk products authorized via the standard route, according to findings published in a JAMA Internal Medicine research letter on Monday.
An analysis of 230 Class III products approved from 2005 to 2015 found 62% of devices that received some form of expedited review were recalled, compared to 30% of those with standard review. Despite having special status, priority review took longer than the standard process, on average.
With FDA stepping up its Breakthrough Devices Program, the researchers used the data to argue for the establishment of new safeguards during the approval process and stronger postmarket surveillance practices.
FDA first created an expedited review process for medical devices in 1994. The process has been through multiple rounds of changes since then — most recently manifesting in the Breakthrough Devices Program — but the focus on expediting progress of devices that offer significant advantages over existing treatment options has remained constant.
Now, researchers at New York University and University of California, San Francisco, have sought to determine certain impacts of priority review programs. To do so, the researchers analyzed how long it took FDA to reach decisions about the Class III devices it approved from 2005 to 2015, and looked at the postmarket safety records of the products through mid-2018.
Eighteen of the 29 devices approved under the priority review program were recalled, compared to 60 of the 201 products authorized following a standard FDA assessment. The results suggest devices that received priority review may be more likely to be recalled than their standard counterparts.
The rest of the data paint a mixed picture, with priority review devices being subject to serious recalls sooner after coming to market but not being associated with more adverse events overall.
The researchers also looked at how long it took FDA to perform priority and standard reviews. The analysis showed the median time to FDA approval for priority review devices was 21 months, significantly longer than the 14-month standard review timeline. As the researchers note, that fact likely reflects “the novel and complex nature of the devices in the priority category.”
Novelty and complexity may also explain the differences in the recall data for priority and standard review devices. Class III priority review devices are, by definition, at the leading edge of medtech and therefore prone to coming to market before testing in large numbers of patients enables developers to identify and mitigate all the risks they pose.
With the 21st Century Cures Act empowering FDA to authorize breakthrough devices on the strength of registries and other sources of data beyond clinical trials, the researchers see potential for the recall trends they identified to continue in the coming years. To avoid that outcome, the researchers argue for changes to premarket and postmarket practices.
“Before premarket approval times are shortened, patient protections should be improved. Initiatives might include identifying appropriate safeguards during the approval process, strengthening postmarket surveillance to allow prompt identification of safety concerns, and increased availability and transparency of adverse event reports,” the authors of the study wrote.
The Breakthrough Devices Program is now nearing the point that the balance FDA strikes between speed and safety will start to affect larger numbers of patients. The number of breakthrough designations given out each year ramped up from 11 in 2016 to more than 100 in 2019, leading FDA’s device director Jeff Shuren to predict there will soon be a "steamroll" of marketing clearances or approvals for breakthrough-designated devices.