FDA Best Practices for Selecting Predicate Devices for 510(k) Submission
Today, September 07, 2023, the FDA issued their Draft Guidance for Industry and Food and Drug Administration Staff on best practices for selecting a predicate device for 510(k) submissions.
510(k) submissions are required when medical device companies want to market their Class II devices and need FDA clearance to do so. 510(k)s provide the FDA with evidence that a device is "substantially equivalent" to an already cleared predicate device. A predicate device must have the same intended use and technological characteristics as the new device, and if it does have different characteristics those differences must not introduce new questions of safety and effectiveness.
510(k)s differ from other pathways for FDA clearance. For example, De Novo submissions are required for devices considered new and not similar to already cleared devices, and PMA (Premarket Approval) submissions are needed for devices that pose higher risks for patients.
The document, titled "Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission" identifies four best practices that medical device manufactures should use when seeking to establish Substantial Equivalence in premarket notifications (510(k)).
To summarize, these are:
Use predicate devices that have been cleared using well-established methods, with those methods developed within a consensus environment and/or subject to public comment or peer review as particularly valued.
Use predicate devices that maintain high safety standards, post-market and over time, as the device becomes more widely distributed and commercially used. This means the device has had ample time and uses to reveal any safety issues should they arise.
Medical device manufactures can search the Manufacturer and User Facility Device Experience (MAUDE) Database; Medical Device Reporting (MDR) Database; and MedSun Reports Database to learn about a predicate's post-market safety record.
Use predicate devices that do not have unmitigated use-related or design-related safety issues. This also speaks to post-market impacts, but focuses more on "emerging signals" that suggest a causal link between the device and a safety concern. You don't want to use a predicate device that looks like it might have safety concerns on the horizon.
Note, there may be a modified version of the device that accounts for these signals already cleared, so you might not need to find an entirely new predicated device.
Use predicate devices that have not been subject to a design-related recall. Recalls might be voluntary and tend to be due to design, manufacturing, or labeling defects.
Search the Medical Device Recalls Database to learn if your predicated device has been subject to recall.
Another good practice, though note listed in this Draft Guidance is to search the predicate of your predicate, to make sure there are no safety issues that have flown under the radar, but might lead to safety concerns down the road.