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FDA announces plans to modernize 510(k) pathway for medical devices

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Scott Gottlieb

FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, director of the Center for Devices and Radiological Health, released a statement regarding changes being made to modernize the FDA 510(k) clearance pathway to help keep pace with the increasing complexity of rapidly evolving technology. These changes to the 510(k) clearance pathway are part of the Medical Device Safety Action Plan issued by FDA in April 2018.

“The new technology that we’re seeing holds tremendous public health promise for patients. But with the advances also come new complexities that can make the review of safety and effectiveness more challenging,” according to the statement. “The framework we propose is aimed at efficiently advancing beneficial technology to patients, while solidifying FDA’s gold standard for safety.”

Improving 510(k) pathway

FDA believes driving innovators toward reliance on more modern predicate devices or objective performance criteria when bringing new devices to patients may be the most impactful way to promote innovation and improved safety in the 510(k) program. According to the statement from Gottlieb and Shuren, FDA is looking to promote the use of more recent predicates in comparative testing for safety and effectiveness of new devices.

“To advance these goals, in the next few months [the Center for Devices and Radiological Health] CDRH is considering making public on its website those cleared devices that demonstrated substantial equivalence to older predicate devices,” which was written in the statement. “We’re considering focusing on predicates that are more than 10 years old as a starting point, so that the public is aware of those technologies. Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest improvements and advances.”

Other steps include “developing proposals to potentially sunset certain older predicates and promote the use of more modern predicates” and consider whether this approach should be a requirement in the future.

FDA also intends to finalize guidance establishing an alternative 510(k) pathway in early 2019. The statement noted this alternative pathway will allow “manufacturers of certain well-understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence as a way to make it more efficient to adopt modern criteria as the basis for the predicates that are used to support new products.”

The new approach will be renamed the Safety and Performance Based Pathway.

“Through this new path, a company would demonstrate that a novel device meets modern performance-based criteria that have been established or recognized by the FDA and reflect current technological principles,” according to the statement. “These criteria would reflect the safety and performance of modern predicate devices. 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.”

Increasing safety on devices

FDA has taken steps to increase the predictability and transparency of the 510(k) review process. This includes increasing expectations for the quality and quantity of information required in 510(k) submissions, which has doubled the size of submissions but decreased average total time for FDA to reach a decision.

To reduce the possibility of new or a greater frequency of known risks, CDRH has been working to enhance post-market surveillance systems to include active surveillance capabilities. CDRH will also continue its efforts to eliminate the use of 510(k)-cleared predicates with safety concerns that warranted treating them as high-risk technologies.

“Through a process known as “up-classifying” — meaning that we are re-assigning a device to Class III and requiring premarket approval, our most stringent review pathway, before a device can remain on the market — we can and have made ineligible the use of certain devices as legal predicates,” according to the statement.

However, as noted in the statement, up-classifying devices is time- and resource-intensive and may not be beneficial when swift action is needed for safety concerns. Other tools, such as imposing special controls on a type of 510(k) device and working with manufacturers to mitigate a risk, may be inefficient, and increases the need for additional changes to the 510(k) program.

“We know that some of these proposals may require additional support from Congress,” according to the statement. “But we believe that these are the right steps to advance safety and innovation, and we’re committed to these ideas and committed to working with stakeholders to continue to modernize our policies.”

Additional updates on the status of the Medical Device Safety Action Plan will be provided in the coming weeks, as well as further steps for promoting patient safety, according to the statement.

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