A new draft guidance from the FDA offers insight into the process by which a manufacturer might select a predicate device for a new class II product under the 510(k) program. While this document does not necessarily constitute a new approach to the selection of a predicate device, it does make clear that the FDA strongly prefers that a predicate have a clean record for adverse events (AEs) and device malfunctions.
The FDA published this new draft guidance Sept. 6, 2023, along with two others: a draft for clinical data in 510(k) applications and a draft for evidentiary expectations for implanted 510(k) devices. The predicate best practices draft guidance describes four practices for selecting a predicate device for a 510(k) submission, but the FDA emphasized that this draft does not represent a new statutory or regulatory standard. When finalized, this guidance will be used in conjunction with the 2014 guidance for evaluating substantial equivalence in 510(k) submissions, which clarifies the critical points in the decision-making process the FDA uses to review 510(k) applications.
Draft Guidance a Part of the FDA Safety Action Plan
The general requirements for a determination of substantial equivalence are unchanged, starting with the requirement that the new device has the same intended use as the predicate. The new device should have the same technological characteristics as the predicate unless the developer can demonstrate that the differences raise no new questions of safety or effectiveness. This draft guidance is related to the FDA’s 2018 program for modernizing the 510(k) process, the Medical Device Safety Action Plan, which had included a proposal to eliminate predicates that are at least 10 years old.
However, the FDA reconsidered the 10-year limit after reviewing the feedback for the safety action proposal. Among the reasons for this reversal are that many devices that have been on the market for at least 10 years are still performing well, and that some device types—such as software as a medical device (SaMD)—evolve rapidly and consequently may become obsolete before 10 years have passed.
The four recommended criteria for best practices consist of selection of a predicate that:
- Was cleared based on well-established methods, such as FDA guidance;
- Meets or exceeds expected safety and performance metrics;
- Is free of any unmitigated use-related or design-related safety issues; and
- Has not been the subject of a design-related recall.
In addition to FDA guidance documents, the list of well-established methods consists of FDA-recognized voluntary consensus standards and qualified medical device development tools (MDDTs). Other options for fulfillment of this requirement are the use of a widely accepted method that has been published in the public domain, as well as any methods used by that manufacturer in prior premarket submissions.
The selection of a device that meets or exceeds safety and performance standards should account for any emergent safety signals such as:
- Newly recognized types of AEs;
- An increase in the severity or frequency of a known AE, and;
- New interactions with other medical devices.
The manufacturer should conduct a search of the FDA’s databases, such as the Manufacturer and User Facility Device Experience (MAUDE) database, for information related to AEs.
2016 Emerging Signals Guidance an Important Reference Source
The scope of the third of these four criteria—freedom from unmitigated use-related or design-related safety issues—includes any similar problems experienced with other devices, including multiple similar devices from one or more manufacturers. This section of the draft guidance states that manufacturers should consult the December 2016 emerging signals guidance as a reference for the Agency’s policy regarding emerging safety signals. The emerging signals guidance describes a signal as an indicator of a potentially causal association, or a new aspect of a known association, between a medical device and an AE or series of AEs.
The fourth criterion for selection of a predicate—the use of a predicate without a recall associated with design issues—includes recalls that are undertaken due to the choice of materials. This is in addition to recalls triggered by issues associated with design controls under Part 820.30 of the Quality System Regulation (QSR).
The FDA recommends that premarket submissions include documentation of a developer’s use of the predicate best practices guidance in the selection of a predicate. If a developer selects a predicate that does not fulfill the terms of the guidance, the developer would be required to describe how it will mitigate any known safety or performance issues. This description of how the developer used the predicate best practices guidance would be included in the public release of information about that 510(k) application if the FDA clears the device.
A Device Rejected as a Predicate Still Potentially Useful
It may be helpful to note that this new draft guidance and the FDA’s 2014 substantial equivalence guidance both make clear that the use of multiple predicates is permissible, but the 2014 guidance also allows the use of a reference device to support the application. While a reference device cannot be used to demonstrate substantial equivalence, it may be used to support the scientific methodology or standard reference values described in a 510(k) application.
A 510(k) application should provide a scientific rationale for the inclusion of the reference device, but a device that was rejected as a predicate might still be useful as a reference device. The 2014 substantial equivalence guidance offers other valuable information, such as when a change in the indication for use constitutes a change in intended use. Examples of this include a change in the anatomical structure where the device would be used, and a change in the patient population for which the device’s use is indicated.
The predicate best practices draft guidance has the broadest reach of these three recent drafts released by the FDA, and we will review the remaining two in future blogs. These are important policy documents for the 510(k) program which continues to evolve, a consideration of utmost importance to manufacturers and developers.