FDA Priority Review of High-Risk Medical Devices Linked to More Recalls

Published on April 16, 2020 by Sandy Liebhard

A new study suggests that Class III medical devices (those considered high-risk) are more likely to be recalled if they come to market via the U.S. Food & Drug Administration’s (FDA) priority review program.

FDA Medical Device Approval: Priority Review

Examples of Class III medical devices, which represent about 10% of those regulated by the FDA, include breast implants, implantable pacemakers, and implantable prosthetics.

Under most circumstances, Class III medical devices must be approved through the agency’s stringent pre-market approval program. But in 1994, the FDA introduced priority review in an effort to speed the introduction of breakthrough technologies. To qualify for this program, a device must provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions and meet at least one of the following conditions:

• Represents Breakthrough Technology.
• No Approved or Cleared Alternatives Exist.
• Offers Significant Advantages over Existing Approved or Cleared Alternatives.
• Device Availability is in the Best Interest of Patients.

What the Study Found

To determine the speed and effectiveness of priority review, researchers writing in the Journal of the American Medical Association (JAMA) compared new Class III cardiovascular, orthopedic and general surgery devices approved by the FDA between January 1, 2005, and December 31, 2015.  They analyzed data on 29 priority review devices that and 201 standard review devices.

Their findings suggested median review times were actually longer for medical devices subject to priority review (21 months) in comparison to those that underwent standard review (14 months).  Yet 62% of the priority review devices were eventually recalled versus just 29% of standard review devices.

Recalled devices were also more likely to be associated with adverse events. 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.

Recommendations for Improving Priority Review

“The findings of this study … [raise] concerns about the inherent risks of these first-in-class devices,” the study authors wrote. “Before premarket approval times are shortened, patient protections should be improved.”

The research team suggested several measures to enhance patient protections, including better post-market surveillance to speed identification of safety concerns; greater transparency and availability of adverse event reports; and identification of relevant safeguards during the approval process.