Latest steps to strengthen FDA’s 510(k) program for premarket review of medical devices

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health

In 2018, the FDA’s Center for Devices and Radiological Health achieved several new milestones, including a record-setting year for approvals of novel medical devices. We also focused on advancing several meaningful initiatives and policy proposals aimed at enhancing the safety of medical devices, including the safety of devices cleared through the FDA’s 510(k) review process.

We articulated those concepts early in the year as part of the FDA’s Medical Device Safety Action Plan and most recently with our announcement of changes to strengthen the 510(k) program. The Safety Action Plan described actions we’ve taken over the past several years to enhance device safety and outlined our vision for how the agency can build on these initiatives to further assure the safety and effectiveness of medical devices.

As we start the new year, we’re dedicated to executing on the commitments we laid out last year and implementing our proposed new policies. As we outlined this past November, one of our goals is to ensure that the 510(k) program is keeping pace with the important innovations we’re seeing in device development. We believe this means that, where appropriate, new medical devices coming to market under the 510(k) pathway should either account for advances in technology that can improve the safety or performance of these products, or demonstrate that they meet more modern safety and performance criteria. Today, we’re pleased to announce two developments toward advancing this policy effort.

First, the FDA posted its final guidance establishing the framework for the Safety and Performance Based Pathway¹. The new name for this guidance reflects our focus on advancing new products with improved safety and performance. This option for 510(k) clearance will modernize our approach to moderate risk devices by allowing manufacturers to use objective performance criteria established or recognized by the FDA to facilitate demonstration of substantial equivalence of their new products to legally marketed devices. Under the traditional approach, manufacturers often rely on comparative testing against a device already on the market, known as a predicate device, to show that a new device is as safe and effective as the predicate device. But, the predicates may be older and, consequently, they may not reflect the modern technology embedded in new devices of that type.

For appropriate device types, the Safety and Performance Based Pathway will ensure that the performance characteristics of new devices are evaluated against a set of objective, transparent and well-validated safety and performance metrics. It’s important to note that devices using this pathway will still have to meet our current standards for reasonable assurance of safety and effectiveness before they can be marketed. The benefit of this approach is that the pathway will benchmark modern technology against modern standards while, at the same time, offering a potentially more efficient way to demonstrate that a new device is substantially equivalent to devices already on the market, and thereby ensure patients have timely access to beneficial products. We also believe this new approach may drive greater market competition to develop safer devices. By using this pathway, manufacturers would have demonstrated that their products meet objective safety and performance criteria that are based on modern technological principles.

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