To begin, let’s refresh our memories of the legal standard of substantial equivalence from section 513(i) of the Federal Food, Drug, and Cosmetic Act. Substantial equivalence means that when a device is compared to a predicate device, the device has the same intended use as the predicate device AND has the same technological characteristics as the predicate OR has different technological characteristics that do not raise new questions of safety and effectiveness. There is an assumption that the predicate device has a level of safety and efficacy that can be assumed to be in the new device that is “substantially equivalent.”

Interestingly, FDA has just issued a draft guidance recommending best practices for choosing a medical device. This new guidance comes out of FDA’s 2018 announcements on changes to modernize the 510(k) program. The Agency, wanting more recent predicate devices to be used, had suggested that predicate device selections be limited to those cleared within the last ten (10) years. Upon review of public comments, the Agency acknowledges this approach is not best for promoting safer and more effective devices. 

Now the Agency is proposing that a broader set of characteristics be considered when choosing a predicate device, including:

1. Predicate devices using FDA guidance and FDA recognized voluntary consensus standards, i.e., well-established methods rather than test methods that are not widely known or scientifically accepted. 
2. Predicate devices with little or no reports of injury, death and malfunction related to a potential predicate device using FDA databases.
3. Predicate devices without unmitigated use-related or design-related safety issues such as emerging signals that a device is associated with adverse events.
4. Predicate devices without an associated design-related recall.

The draft guidance provides examples of how to present the information in a 510(k), to provide transparency as to how predicate devices were researched and how the selection was made. The comment period closes December 6, 2023, so don’t procrastinate!