New Draft Guidance Document on Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission

Boston MedTech Advisors Blog, January 2024

Medical device manufacturers are required to submit a Premarket Notification 510(k) submission to FDA if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified from the original, potentially affecting its safety or effectiveness. These 510(k) submissions allow FDA to determine if the new device to be marketed is “substantially equivalent” (SE) to a, legally marketed, predicate device. To claim SE, the new device should have the same intended use as the predicate device and the same technological characteristics as the predicate device (or different technological characteristics that do not raise different questions of safety and effectiveness).¹

The process of choosing the right predicate device can be challenging, especially for newer device developers that do not have previous versions of their own device to use as a predicate. Therefore, FDA developed the premarket notification [510(k)] program, which, since its inception has undergone several statutory changes to adapt to changing circumstances and to accommodate the evolving medical device landscape.

In an effort to modernize the premarket notification [510(k)] program, FDA published in September 2023 a draft guidance, focused on best practices for selecting a predicate device: “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission.”

In accordance with the new draft guidance, FDA recommends device manufacturers consider, whenever possible, four best practices when selecting a predicate device.

This guidance was developed to help manufacturers assess the ideal predicate using best practice guidelines. This draft guidance is intended to potentially improve the predictability, consistency, and transparency of the 510(k) premarket review process.

This is not FDA’s first attempt to revise the predicate selection guidance. In 2019, FDA considered promoting the use of more modern predicate devices by making public, on its website, devices that were cleared based on predicates that were more than ten years old, so the public was made aware of those technologies. However, following public comments, this proposal was discarded in favor of selecting a predicate device based on their characteristics and best practices rather than just their age.

In accordance with the new draft guidance, FDA recommends device manufacturers consider, whenever possible, four best practices when selecting a predicate device:

Select a valid predicate device that was cleared using well established methods which include, where applicable, the use of current FDA recognized voluntary consensus standard, an FDA guidance document, a qualified medical device development tool, or a widely available and accepted method published in the public domain or in scientific literature for the context of use or that has been found acceptable through the submitter’s own previous premarket submission.
Select a valid predicate device that continues to perform safely in its intended environment. This entails researching the severity or frequency of device-related adverse events, both known or unanticipated, new product-product interactions, and/or device malfunctions.
Select a valid predicate device that does not have unmitigated use or design-related safety issues due to potential to impact patient management decisions and/or the known benefit-risk profile of the device.
Select a valid predicate device that has not been subject to a design-related recall due to design defects, manufacturing defects, or labeling defects.

To promote transparency, FDA also recommends that the predicate selection process be detailed in the publicly accessible 510(k) summary of the submitted device. Furthermore, a description of the performance testing and mitigations conducted to address any known safety or effectiveness concerns with the predicate device should be included.

The draft document has received 33 comments³ to date, raising meaningful questions about the implications of FDA’s proposed new approach, and the potential practical challenges associated with its implementation. Though the recommendations provided in this draft guidance are not intended to propose any changes to the current way FDA evaluates SE¹, the proposed approach potentially conflicts with the SE and least burdensome principles in that a submitter may need to show that the new device is safer and/or more effective than the predicate, i.e., mitigating the concerns with the predicate. This could potentially lead to significant and unpredictable data demands during the 510(k) review.

FDA is in the process of considering all comments while finalizing the guidance document.

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References:

Guidance for Industry and Food and Drug Administration Staff “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” July 2014. https://www.fda.gov/media/82395/download
Draft Guidance for Industry and Food and Drug Administration Staff “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission” September 2023. https://www.fda.gov/media/171838/download
https://www.regulations.gov/docket/FDA-2023-D-3134/comments