FDA Looking to Make Changes to 510(k) Process

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On November 26, 2018, United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced changes to the process for approving medical devices for the United States market. The change in policy aims to revamp the popular 510(k) clearance pathway, the process for approving devices based on predicates, or devices that are substantially equivalent to an already-approved device.

The 510(k) process allows the FDA to recognize that “medical devices exist across a continuum of complexity and risk and that the scope of premarket review should reflect this risk continuum.” A one-size-fits-all regulatory approach would not optimize public health outcomes, would not be efficient in advancing beneficial new technologies to patients, and would not allow the FDA to effectively prioritize its scientific resources.

In his comments about the plan, Commissioner Gottlieb emphasized that as medical technology continues to become more complex, interconnected, and advanced, the predicates on which devices are based have become less relevant. Therefore, the agency is proposing to limit the age of predicates to ten years to avoid comparing current technology to outdated technologies. This change would therefore require an approval outside of the 510(k) process if the comparable device being used is older than a decade.

The vast majority (roughly 80%) of all FDA reviews of medical devices are done through the 510(k) process. An overhaul of that process may result in significant disruption in the FDA’s approval of medical devices.

Gottlieb made to sure offer his support for the program, noting, “We believe firmly in the merits of the 510(k) process.” However, he also seems to understand that technology is growing by leaps and bounds, stating, “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.”

In 2019, the FDA intends to release guidance that will establish an alternative 510(k) approval pathway based on objective safety and performance criteria rather than on a predicate device, and eventually the FDA envisions solely using that pathway as opposed to comparisons to older devices. Under this approach, “Manufacturers would be able to demonstrate that their products meet or exceed objective safety and performance criteria that are based on modern technological principles,” wrote FDA Commissioner Scott Gottlieb, M.D. and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren, M.D. The statement also noted that Congressional approval may be necessary to implement some of the proposals outlined.

FDA is Changing with the Times

This announcement is the latest in the FDA’s updates aligned with the Medical Device Safety Action Plan released last April. Just last week, the FDA announced changes and advances in post-market surveillance of medical devices, and now seems to be turning its attention to the initial approval process.

Gottlieb seemed to allude to all of the change that seem to be happening, stating, “In recent months, we’ve taken many new steps to advance these goals. Many of these efforts aim at adopting a more modern process that allows the FDA to more readily incorporate new technologies that improve the safety and performance of medical devices into new predicates to serve as benchmarks for future clearances.”

Prior to the FDA taking any additional steps, the Agency will Before proceeding, seek public feedback on whether it should make public those devices or those manufacturers who make technologies that rely on predicates that are more than 10 years old, whether other criteria should inform its point of reference, and whether there are other actions it should take to promote the use of more modern predicates.

AdvaMed Response

In response to Commissioner Gottlieb’s announcement, AdvaMed released a statement, cautioning that the 10-year cutoff for predicates could be “arbitrary.” “It is our hope that…the agency will recognize that in some cases there are legitimate reasons for using older predicates, and that for some devices where the technology has changed little using those older predicates still makes sense,” wrote AdvaMed President and CEO Scott Whitaker.

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