Research examines FDA-designated “breakthrough” devices
Striking the balance between getting innovative devices to patients with scientifically assuring clinical benefits and risks is one of the most difficult tasks facing the Food and Drug Administration (FDA). To address this challenge, Congress established the FDA Breakthrough Devices Program (BDP) under the 21st Century Cures Act of 2016. And now, a multi-institutional team led by researchers at The Ohio State University College of Medicine has completed the first comprehensive evaluation of this high-priority program.
The team recently published their study, titled “FDA Authorization of Therapeutic Devices Under the Breakthrough Devices Program,” in JAMA Internal Medicine. The investigators, including Vinay Rathi, MD, MBA, an otolaryngologist and a health policy researcher at The Ohio State University Wexner Medical Center, and James Burke, MD, professor of Neurology at the Ohio State College of Medicine, found that while the FDA authorizes most breakthrough-designated devices in a timely fashion, there remains a great deal of uncertainty about the risks and benefits. Premarket clinical studies are often limited in rigor, and the FDA rarely requires post market studies to confirm devices’ safety and effectiveness.
“The Breakthrough Devices Program can help accelerate technological development and patient access,” Dr. Rathi says. “But more rigorous regulatory assessment would help ensure that these devices are truly ‘breakthroughs.’”
Dr. Rathi is an expert in the FDA’s regulation of medical devices. His work helps promote the safe and effective use of medical devices and has been published widely and featured in outlets such as The New York Times, The Washington Post, CBS News and Forbes.
