Scott Gottlieb: How his time at the FDA affected medtech

The Food and Drug Administration commissioner Scott Gottlieb has tendered his resignation, meaning he will leave his post next month.

In his resignation letter to the U.S. Secretary for Health and Human Services, Gottlieb said: “Over the past 23 months I’ve been privileged to work with an outstanding team at the Food and Drug Administration, and to collaborate with the professional staff on the implementation of many meaningful initiatives that have advanced public health.”

During his time at the FDA, Gottlieb has overseen the launch of the Safer Technologies Program (STeP) and new guidance on breakthrough devices in the Breakthrough Device Program.

Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed) thanked Gottlieb for his work at the FDA: “During his tenure as FDA commissioner, Dr. Gottlieb has been a tireless advocate for improved patient care and for promoting innovative solutions to our most pressing health challenges, including greater use of medtech to combat the opioid crises. We wish him well in his future endeavours.”

One of the key moments at his time at the FDA has been tackling widespread opioid addiction. Recently eight medical device companies were selected to help prevent and treat opioid use disorder – including predicting the risk of addiction, as well as being able to detect the problem.

The FDA has also worked alongside major technology companies such as Apple, Fitbit and Johnson & Johnson to streamline the approval process for digital health products by assessing the developer rather than the product.

Another challenge aside from the opioid epidemic was cybersecurity, whereas back in November the Department for Health and Human Services found the FDA’s plans and processes were deficient for addressing cybersecurity compromises in medical devices.

Gottlieb also highlighted the modernisation of 510(k), which accounts for medical device approval processes in order to accommodate rapidly advancing technologies – perhaps his lasting legacy when it comes to the medtech industry.

At the time of updating 510(k) process, Gottlieb said: “In the 510(k) pathway, manufacturers generally rely on comparative testing against predicate devices to show that a new device is as safe and effective as the predicate device. Older predicates might not closely reflect the modern technology embedded in new devices, or our more current understanding of device benefits and risks. In some cases, the predicate could be decades old. Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

“We believe that newer devices should be compared to the benefits and risks of more modern technology; that is why we’re looking at ways to promote the use of more recent predicates. To advance these goals, in the next few months CDRH is considering making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are more than 10 years old as a starting point, so that the public is aware of those technologies. Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest improvements and advances.”