FDA plans ‘generational’ overhaul of medical device approvals to make way for new technology

Scott Gottlieb FDA
FDA Commissioner Scott Gottlieb said the agency is moving forward with changes to modernize the 510(k) process. (FDA)

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."


2019 Drug Pricing and Reimbursement Stakeholder Summit

Given federal and state pricing requirements arising, press releases from industry leading pharma companies, and the new Drug Transparency Act, it is important to stay ahead of news headlines and anticipated requirements in order to hit company profit targets, maintain value to patients and promote strong, multi-beneficial relationships with manufacturers, providers, payers, and all other stakeholders within the pricing landscape. This conference will provide a platform to encourage a dialogue among such stakeholders in the pricing and reimbursement space so that they can receive a current state of the union regarding regulatory changes while providing actionable insights in anticipation of the future.

“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.

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.

RELATED: Gottlieb announces new efforts to streamline device approval process, with help from insurers

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.

RELATED: FDA updates medical device premarket guidance to include cybersecurity recommendations

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.

Suggested Articles

We need our federal programs and policies to reflect the goal of improving the health of both women and men.

Two lawsuits were filed suing the Trump administration to overturn a new rule that would allow healthcare workers to deny care over religious or conscience…

Policy changes are affecting how investors view the skilled home health market and paving the way for potential strategic acquisitions.