On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, consistency, and transparency” for the 510(k) premarket review process. In this post, we discuss the two new draft guidances with broad applicability to the 510(k) Program1:
Under the Federal Food, Drug, and Cosmetic Act, a submitter must demonstrate in its premarket notification submission (commonly referred to as a “510(k)”) that its device to be marketed is substantially equivalent to a predicate device. To establish substantial equivalence, the FDA must find that (i) the submitted device and predicate device have the same intended use and (ii) that the submitted device and predicate device have the same technological characteristics, or if they do not, that the differences in technological characteristics of the submitted device do not raise different questions of safety and effectiveness than the predicate device and that the submitted device is as safe and effective as the predicate device.
The two draft guidances are generally additive to existing policies — including a July 2014 FDA guidance, “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k]” (the “510(k) Program guidance”) — and address a number of fundamental issues of concern with the 510(k) process.
In this post, we highlight some key takeaways from the two draft guidances.
Best Practices for Selecting a Predicate Device
Following review of public comments received from its 2019 public notice, the FDA determined that a “best practices” focus when selecting predicate devices would be a more appropriate method to modernize the 510(k) Program with regards to the use of predicate devices, as opposed to focusing on the age of the predicate device on the market.
The Predicate Device guidance explains that a submitter should first consider the list of legally marketed devices to identify “valid predicate devices.” The Predicate Device guidance then sets forth four best practices that the FDA recommends using to narrow the list of valid predicate devices to select a predicate device:2
The Predicate Device guidance concludes with recommendations on how to use the four best practices and with a few examples that all use a new chart to summarize assessments involving the best practices.
Finally — and notably — the FDA recommends that submitters include within their 510(k) Summaries a narrative explaining their selection of the predicate device and how the submitter utilized the best practices in reaching its decision to use such predicate device.
Recommendations for the Use of Clinical Data in 510(k) Submissions
The Clinical Data guidance provides recommendations for when clinical data may be required to demonstrate that a submitted device is substantially equivalent to a predicate device.
The Clinical Data guidance is consistent with and expands upon the relatively brief discussion of this fundamental topic in the FDA’s 510(k) Program guidance. As explained in both guidances, when nonclinical data is insufficient or when the available scientific methods are not acceptable, the FDA may request a submitter to provide clinical performance data to support a determination of substantial equivalence.
The Clinical Data guidance expands upon the discussion of three common scenarios in which clinical data might be required and introduces a fourth scenario:
The FDA will host a webinar on the draft guidances on October 26, 2023. Further, the FDA is accepting comments and suggestions on these draft guidances until December 6, 2023.
[1] The third guidance in the trio, “Evidentiary Expectations for 510(k) Implant Devices,” complements existing device-specific guidances and is intended to serve as a “primary resource on general recommendations for all implant devices for which a 510(k) is required.”
[2] *When conducting a search, a submitter should review the following FDA databases:
**Information about emerging signals and safety communications is available on the Medical Device Safety and CBER Safety & Availability (Biologics) websites.
***Information about recalls is available on the Medical Devices Recalls Database.
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