On September 6, 2023, the FDA released three draft guidance documents that seek to “modernize” the 510(k) premarket notification process. Ever since the FDA first proposed “transformative new steps” to the program in 2018, the agency has promised to further update the 510(k) clearance pathway in an effort to better balance technological innovation and patient safety. In issuing these draft guidance documents, the FDA has followed through on that promise.
The first document, Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission, outlines four best practices that 510(k) submitters should follow when choosing a predicate device. First, the predicate device should have been cleared by “well-established methods,” such as an FDA-recognized voluntary consensus standard. Second, the predicate device should “meet or exceed expected safety and performance,” requiring submitters to continually be on the lookout for new information about the device’s use and whether any safety concerns have arisen. Third, the predicate device should not have any “unmitigated use-related or design-related safety issues.” Finally, the predicate device should not be associated with a “design-related recall,” such as if one of the materials that was used in the design of the device is recalled.
While these best practices are not intended to introduce any changes to relevant regulatory standards, they do propose a new process for predicate device selection and evaluation that may well alter the 510(k) process in practice. For instance, while submitters are not currently required to do anything onerous to justify their choice of predicate device, the best practices indicate that submitters will need to spend much more time justifying their predicate device choices. Specifically, the guidance suggests that submitters could demonstrate compliance with the best practices by including a table in their submission detailing how each valid predicate device under consideration meets (or does not meet) each of the four best practices. Notably, the guidance contemplates a scenario where no valid predicate device accords with the best practices, and in such cases the FDA recommends that the submitter describe “how any known concerns with the valid predicate device have been mitigated with the subject device.” In other words, the submitter would have to articulate how its own device improves upon (and is not just substantially equivalent to) the predicate device in question.
The second document, Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions, outlines various scenarios where clinical data may be necessary to support a 510(k) submission. Notably, the draft guidance indicates that non-clinical testing may be inadequate to establish substantial equivalence in certain circumstances, such as when new risks are identified after a predicate device has been introduced into the marketplace. In doing so, this guidance signals that the FDA may be raising the bar on 510(k) submitters, calling on them to submit clinical data to show substantial equivalence in some cases.
The third document, Evidentiary Expectations for 510(k) Implant Devices, provides generally applicable recommendations for implants where a 510(k) is required. It outlines various questions that submitters should consider when determining the evidence they may need to support their submissions, such as the intended duration of the implant, the indications for use of the device, clinical performance testing, non-clinical testing, and patient experience information.
At this point, these documents are just draft guidance—they have been issued only for the purpose of public comment. However, they do demonstrate the FDA’s current thinking on the 510(k) program and its commitment to further updating it. More importantly, these guidance documents, if implemented, have the potential to alter the 510(k) process. For instance, these voluntary best practices may well evolve into a de facto requirement that companies do more than just demonstrate “substantial equivalence” to any given predicate device—they may also need to demonstrate that the predicate device they chose was a better choice than an alternative predicate device because it accords more closely with the guidance documents’ best practices.