Priority reviews for class III devices increase likelihood of recalls, study finds

Regulatory NewsRegulatory News | 03 April 2020 |  By 

A research letter published in JAMA Internal Medicine this week finds that class III medical devices that receive expedited reviews are more likely to be recalled, and after spending less time on the market, than devices that undergo a standard premarket approval (PMA) review.
FDA has offered expedited reviews for promising new devices in various forms for decades. In 1989, the agency issued a general program memorandum detailing processes for expedited reviews of investigational device exemptions (IDEs) and PMAs. FDA further developed expedited review processes for devices in subsequent memoranda and guidance in the 1990s and 2000s, eventually leading to its priority review program and expedited access pathway.
FDA’s current breakthrough device program, which supersedes those programs, was created under the 21st Century Cures Act and amended by the FDA Reauthorization Act of 2017.
Research Letter
The research, conducted by JAMA Internal Medicine editor Rita Redberg and colleagues at the UCSF School of Medicine and New York University, looked at all 230 class III devices approved by FDA from 2005 to 2015.
Of those devices, 201 received a standard review and 29 received a priority review. According to the authors, devices that received a priority review were twice as likely to be recalled compared to standard PMAs (29.9% versus 62.1%) and were recalled a median 6.5 months sooner after entering the market.
When looking at Class 1 recalls, FDA’s most serious recall classification for devices, devices that received a priority review were recalled a median 9.5 months sooner.
“This regulatory emphasis on speed of approval over a strong evidence base for safety and effectiveness for high-risk devices is concerning. Safety data are already sparse at time of approval; preapproval device studies are often small, with short follow-up times,” the authors write.
They also posit that medical device makers will increasingly turn to expedited review pathways if available, as has been the trend for drugs and biologics.
In light of their findings, the authors call on FDA to increase patient protections for priority devices, including “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.”
Contrary to what the name would imply, priority reviews also took longer than standard reviews to complete across all device types, taking a median 21 months for priority reviews and 14 months for standard reviews.
FDA has long acknowledged that devices that qualify for expedited reviews may take longer to review, as they are often more complex and raise novel scientific issues. However, as FDA explains in its final guidance on the breakthrough devices program, it believes the program “may enable patients to have more timely access to these devices than they would otherwise because of earlier interaction between FDA and sponsors during the device development process.”
The authors draw a similar conclusion, but note there could be other “additional, unrecorded factors” could contribute to the disparity between the review times.
JAMA Internal Medicine


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