Certain medical devices with FDA priority review have higher recall rates
High-risk, or class 3, medical devices that underwent FDA priority review had higher recall rates and less time on the market before serious recalls vs. high-risk devices that received standard review, data published in JAMA Internal Medicine showed.
“The FDA requires that high-risk (class 3) medical devices undergo premarket approval review, the most stringent path through which devices enter the market,” Caroling Ong, MD, MHS, first-year cardiology fellow in the division of cardiology at NYU Grossman School of Medicine, and colleagues wrote. “Since 1994, in an effort to enable breakthrough technology to reach market faster, the FDA has also offered priority review.”
To determine the speed and effectiveness of these regulatory routes, Ong and colleagues compared new class 3 cardiovascular, orthopedic and general surgery devices privy to premarket approval between Jan. 1, 2005, and Dec. 31, 2015. Ex vivo and in vitro devices were not included. Data from 29 devices that received priority review and 201 devices that received standard review were analyzed.
Researchers found that review times were longer for priority review than for standard review (median, 21 months; interquartile range [IQR], 10-35 months vs. median, 14 months; IQR = 9-22 months; P = .04). Despite longer review time, devices with priority review were more likely to be recalled than those with standard review (62% vs. 29.9%; P = .001) and had shorter time from approval to being in the highest recall class (HR = 2.96; 95% CI, 1.74-5.02). The length of approval time and device type were not linked to the likelihood of recall.
Further, devices that were recalled were more likely to have an adverse event tied to its use (OR = 1.8; 95% CI, 1.01-3.23) than those that were not recalled. There was no difference in the number of adverse events reported for devices approved by either regulatory route during a median follow-up of 7 years (IQR = 4-11 years).
“The findings of this study ... [raise] concerns about the inherent risks of these first-in-class devices,” Ong and colleagues wrote. “Before premarket approval times are shortened, patient protections should be improved.”
To facilitate such protections, researchers suggested enhancing devices’ postmarket surveillance to allow immediate identification of safety concerns; making adverse event reports more transparent and available; and identifying relevant safeguards during the approval process. – by Janel Miller
Disclosures: The authors report no relevant financial disclosures.