Lessons Learned From the FDA's Regulation of Emerging Technologies

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In a commentary published on the JAMA Forum, former FDA Commissioner Scott Gottlieb, MD, recalls the lessons he learned during his time overseeing the FDA’s approach to regulating medical technologies. With the recent boom in artificial intelligence (AI), and its ability to create language models on clinical datasets, there is great potential for the advancement of medicine. However, there is uncertainty regarding how the FDA will regulate these new technologies, according to Gottlieb.

“In approaching this challenge, lessons can be drawn from how the FDA has approached regulation of other new technologies,” Gottlieb wrote. “I faced some of these issues when I served as the FDA commissioner from 2017 through 2019.”

The first lesson Gottlieb recalls is beginning with established processes.

“The agency has established methods for evaluating existing technologies, and in almost all cases, new technologies can fit into one of these channels,” he wrote. “This strategy enables innovators to enter the market more quickly than if they were to forge a brand-new path, and once marketed, developers can use the experience gained from real-world use to expand the applications of a new technology.”

Gottlieb uses the Apple Watch as an example for this lesson. In 2018, it was approved by the FDA to be used as a medical device “for low-risk use in the detection of irregular heart rhythms such as atrial fibrillation in healthy individuals who had not already been diagnosed with a heart disorder.” Fast forward to 2022 and Apple received clearance from the FDA to use the device in patients with a known heart disorder.

When the FDA first reviewed the device, many feared the agency would want to fully dissect it. Instead, the agency shifted to the manufacturer’s overall body of work to validate the product. “The approach fosters a more dynamic and responsive regulatory environment,” Gottlieb wrote. “As innovators improve their validation processes and postmarket oversight, they can benefit from less burdensome premarket regulations, thereby encouraging new advances.”

The second lesson is taking a risk-based approach to regulation. Gottlieb recalls that by 2017, some stem cell products were found to pose serious risks of harm to patients. This followed earlier legislation from the FDA that allowed stem cell “clinics” to operate largely free of oversight.

In 2019, the agency began exercising enforcement discretion over certain stem cell procedures. One such procedure involves “extracting a patient’s blood, processing it to concentrate the platelets, and then injecting this blood product back into the patient,” Gottlieb wrote. While there was not enough evidence to prove the procedure’s benefits to the FDA, it was judged to be low-risk under certain conditions.

“By carving out some low-risk activities, it allowed the agency to focus its resources on high-risk interventions,” Gottlieb wrote.

The third and final lesson is utilizing existing authoritative benchmarks. Gottlieb recalls this lesson was put to use in 2018 with the FDA’s then-new policy for regulating next-generation sequencing. To clear the uses of tests, the agency allowed developers to validate their tests against recognized databases, such as ClinGen. This provided an efficient path for approvals.

Gottlieb concluded, “To enable the safe and effective adoption of new medical technologies, regulatory policies must often be as creative as the advances being delivered to health care professionals and patients. Past precedents provide a guidepost for how regulators can enable the adoption of brand-new platforms, such as artificial intelligence devices.”

Reference

1. Gottlieb S. Strategies for Regulating Disruptive Medical Technologies. JAMA Health Forum. 2023;4(12):e235460. doi:10.1001/jamahealthforum.2023.5460