The Food and Drug Administration (FDA) is preparing to implement changes to its medical device clearance process that would rely far less on older predicate devices and offer a modernized pathway for high-tech medical innovations.
The changes, outlined by the agency’s top officials on Monday, represent a significant shift in the way the FDA approves devices for marketing in the U.S., a process first introduced more than 40 years ago. Specifically, the agency plans to change the 510(k) pathway required for new medical devices to account for advances in medical technology, FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, said in joint statement.
In 2017, 82% of all medical devices were cleared through the 510(k) pathway. The officials said they are "seizing the chance to make a generational change in the framework for 510(k) reviews."
“We believe firmly in the merits of the 510(k) process. But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices,” they said. “In short, we believe that it’s time to fundamentally modernize an approach first adopted in 1976, when Congress considered the vast diversity of devices that would become subject to the FDA’s regulatory oversight.”
One major change would shift the industry away from relying on comparisons to older “predicate” devices. Generally, manufacturers use comparative testing against those predicate devices to show that a newer device is safe and effective. But Gottlieb and Shuren said one in five 501(k) approvals were cleared based on comparisons to a device that was more than a decade 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.— Scott Gottlieb, M.D. (@SGottliebFDA) November 26, 2018
To jumpstart that shift “in the next few months,” CDRH is considering publicizing devices that were approved based on comparisons to predicate devices more than 10 years old.
“Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest improvements and advances,” the officials said.
Although the agency does not believe devices that rely on old predicates are unsafe or need to be removed from the market, greater transparency could facilitate competition among manufacturers, incentivize device makers to use more modern predicates and ensure new devices align with modern technology.
The FDA said it is considering sunsetting certain older predicates, which may require additional support from Congress.
The agency also plans to move forward with proposals outlined in its Medical Device Action Plan, issued earlier this year. In “early 2019” the FDA plans to finalize guidance establishing an alternative 510(k) pathway renamed the “Safety and Performance Based Pathway,” Gottlieb and Shuren said. Manufacturers would meet performance-based criteria that “reflect current technological principles.”
“We’d like this efficient new pathway to eventually supplant the practice of manufacturers comparing their new device technologically to a specific, and sometimes old, predicate device,” they added.
The changes are expected to increase the number of De Novo device approval applications used for new unclassified devices. The agency plans to issue a proposed rule in the next few weeks clarifying procedures and requirements for De Novo applications.
The announcement comes on the heels of a blockbuster report from the International Consortium of Investigative Journalists, which detailed how medical devices have led to serious patient harm, in part because of a lack of oversight from the FDA and other regulators across the globe.
Under Gottlieb, the FDA has pushed to modernize its approval processes to account for new technology and account for the rise in digital health tools, launching a precertification pilot program with some of the largest technology companies in the world. The agency has also emphasized the need for more robust cybersecurity, recently makings several change to premarket guidance that requests manufacturers to include a list of hardware and software components so healthcare organizations can better respond to an attack.