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FDA’s Refreshed Approach to Device Safety Would Require Major Changes to 510(k) Program

On November 26, 2018, FDA Commissioner Scott Gottlieb and device center director Jeff Shuren issued a statement outlining a plan to modernize the 510(k) premarket review program to bolster medical device safety. The 510(k) program relies on a device being compared to a legally marketed predicate device; i.e., a similar device that was already determined to be legally marketable. Most devices come to market through the 510(k) pathway.

FDA’s announcement contains three key points.

  1. FDA wants device manufacturers to use more modern predicate devices or objective performance criteria when they seek clearance of their 510(k).

According to FDA, nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. FDA suggests that means some devices are not continually improving, but is it the role of FDA to encourage such improvement and are more modern predicates needed in every situation? The agency is taking a forward-leaning approach rather than playing the part of a passive regulator, which should be understood alongside recent news that portrays FDA as too slow to respond to safety issues. But there may be reasons to use an older predicate that have nothing to do with safety, such as when a type of device does not evolve quickly.

  1. FDA is considering publicizing devices that were cleared based on comparison to a predicate that is more than 10 years old.

FDA would seek public comment on this approach, including if other criteria should be considered and if there are other ways to promote the use of more modern predicates. Despite FDA’s repeated statement that relying on an old predicate does not mean a device is unsafe, this seems like an obvious attempt to publicly shame companies into using more modern predicates by creating an impression that there is something wrong with devices that were cleared based on older predicates (otherwise, a layperson may reasonably ask, why publish a list of them?). This is an interesting approach for two FDA leaders—Drs. Gottlieb and Shuren—who, based on my experience working with them, favor market-based approaches rather than government intervention. That is, if patients and doctors prefer devices based on more modern predicates, the market for devices based on old predicates will dwindle. Drs. Gottlieb and Shuren would likely respond by saying this is a small nudge to the market to improve conditions, necessary especially because of the potential benefits for patient safety.

  1. FDA plans to finalize in early 2019 its Expanded Abbreviated 510(k) draft guidance, issued in April 2018, and rename the approach the “Safety and Performance Based Pathway”.

In its April 2018 Medical Device Safety Action Plan, FDA said that allowing device manufacturers to use objective performance criteria to demonstrate substantial equivalence (rather than comparison to a predicate) may drive greater market competition to develop safer devices. The draft Expanded Abbreviated 510(k) guidance issued that same month was further evidence of the agency’s plans to encourage use of objective performance criteria rather than predicate devices. The November 26, 2018 announcement removes any uncertainty about FDA’s vision: the new pathway is envisioned to “supplant the practice of manufacturers comparing their device technologically to a specific, and sometimes old, predicate device.” The word “technologically” is important because, without a change to the law, new devices must still have the same intended use as a predicate device, but the technological characteristics of the new device can be compared to safety and performance criteria rather than the technological characteristics of the predicate. This is similar to the existing Abbreviated 510(k) pathway.

Why is FDA doing this?

Coupled with April 2018’s Medical Device Safety Action Plan, the November 26, 2018 statement should be understood as a subsequent chapter in FDA’s story to refute public perception that it cannot or does not appropriately respond to unsafe devices. Such perception has not been helped by recent high-profile exposés involving the female contraceptive device Essure, hip implants, vaginal mesh, and other devices. The November 26, 2018 statement was published the same day AP published a story about safety issues with spinal-cord stimulators.

FDA is typically a reactive agency largely because it must act within the statutory limits set by Congress; when an issue arises for which FDA is not legally equipped to handle, it must find alternative solutions (such as asking companies to make changes to devices and/or labeling and making public statements) until Congress acts. The November 26, 2018 statement is a proactive approach to improving the safety of devices generally. Dr. Shuren has said that safety and innovation are not opposites; in fact, many new, innovative devices are inherently safer because they incorporate mitigations to address known safety issues. FDA states that patient and consumer safety is its first priority—this is an example of the agency proactively crafting policy to advance that priority.

Anticipated Reaction

I have heard mixed reviews on this approach from the device industry. Some medical device manufacturers have complained that it is difficult to show substantial equivalence (the 510(k) clearance standard) between a new device and a decades-old predicate and welcome an alternative approach. Others have said that FDA should not mandate use of the new pathway or otherwise suggest that devices that go through the traditional approach are somehow less safe.

The device community may be wondering how this is different from the existing Abbreviated 510(k) pathway. Based on my experience at the agency, I think this refresh of the abbreviated model is paving the way for getting rid of predicates. While FDA is currently approaching this policy change via guidance, the agency’s statements suggest they are looking to work with Congress to codify the new pathway in statute, which could, over time, allow the agency to require a manufacturer use the new pathway and could open to the door to eventually eliminating predicates.

The biggest question mark in Congress is House Democrats, who will have the majority starting in January. They should view this as a win for device safety but may be skeptical about a proposal that comes from the same agency pushing for overhauls of lab test and digital health oversight that have not exactly aligned with their priorities. Republicans in both chambers will probably be supportive as long as the new approach remains an option in addition to the current 510(k) review model. Even though FDA wants this new model to supplant the current model, that could be seen as a step in the direction FDA wants to move, and therefore a win.

We’ll continue to follow this proposal and take advantage of opportunities to share comments with FDA and Congress.

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