One of the more common pathways to commercialize a medical device into the United States is through the 510(k) marketing submission, also known as a premarket notification.
This path is used for low to moderate risk devices, where substantial equivalence (SE) must be demonstrated to an existing device on the market, known as a predicate.
This blog examines the FDA’s recent Draft Guidance on Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission.
The process of choosing the right predicate to facilitate a SE decision can be challenging, especially for newer device developers that do not have previous versions of their own device to use as a predicate. As part of the 510(k) modernization initiative by the FDA, the agency has been looking at ways to advance and bring efficiency to the review process. There was an initial critical look at issues surrounding the use of older predicates, however the results indicate that there are some key advantages for using older predicates (e.g., accumulation of long-term safety data). As a result of public comments collected on this topic, the FDA decided to focus their efforts into developing a set of best practices for selecting a predicate to support a 510(k) submission. This has been communicated as a draft guidance document, which was released September 7, 2023.
Before we get into the best practices, the first step in choosing a predicate is to determine if the potential predicate is a legally marketed device (i.e., currently registered with the FDA). The second step is to evaluate if it has the same intended use and that any differing technological characteristics do not raise new questions of safety and effectiveness. Once verified, you can move on to assess whether it’s an ideal predicate using the best practice guidelines summarized below.
The FDA recommends selecting a predicate that was cleared using well-established methods, which include, where applicable, the use of:
Outside of these more prescriptive methods, the FDA also permits widely accepted scientific methods that have been subject to public comment or peer review. When going this route, the more access one has to information available for the predicate the better, but it is understood that this may not always be possible.
Another consideration is how up-to-date and applicable these methods are to the current subject device. Any gaps discovered would need to be filled using updated methods e.g., the latest version of a standard or the use of a best practice, peer reviewed scientific method.
The FDA recommends considering any evidence of safety concerns for the potential predicate. The expectation is to demonstrate that there are no red flags identified with the predicate. This is assessed by looking into any potential adverse events, malfunctions or deaths related to the predicate and whether the fundamental design or use of the predicate contributed to the event. Useful databases include the following:
The FDA recommends looking into use-related or design-related safety issues of your potential predicate. This includes ensuring there are no related ‘emerging signals’, which is what the FDA refers to when there is new information about a device that links it to a safety issue such as an adverse event, where the FDA has done an initial investigation and has determined that there could be an impact to patients or the benefit-risk profile of a device. This is essentially identifying potential problems before they become actual safety issues like an adverse event. Communications about emerging signals can be found by searching the Medical Device Safety
This last item involves investigating whether the potential predicate is associated with a design-related recall. This could indicate a safety related design flaw that was not apparent at the time the predicate went through its own 510(k) evaluation and could render this predicate inappropriate for use. Use the Medical Device Recalls database to see if your potential predicate has any design-related recalls.
Additionally, to promote transparency, the FDA recommends sponsors include a narrative in the 510(k) summary that explains the predicate selection process. This is the portion of the submission that summarizes the safety and effectiveness information of the 510(k) submission and is made publicly available. There may be cases where it is not possible to meet all best practices. Depending on the specific situation and general safety profile of the potential predicate, this may be acceptable.
In summary, although this is only a draft guidance, the presented best practices for predicate selection are based on public feedback and appear quite sensible. If you are still developing your regulatory strategy and are looking at the 510(k) path, I highly recommend reading this guidance and taking the FDA’s advice when selecting your predicate. It will increase your chances for a speedier and more successful route to market.
Deborah Pinchev is StarFish Medical’s Toronto QA/RA Manager. She is inspired to write blogs by her interest in helping companies develop and bring to market new and innovative devices.