FDA Expands Abbreviated 510k Process for Moderate Risk Devices
[Posted on: Thursday, April 12, 2018]
FDA plans to accept 510k applications for medical devices that show compliance with FDA defined standards rather than direct comparison to the predicate device by expanding its abbreviated 510k program under the least burdensome philosophy. FDA will release a list of 510k devices that could use this new program along with consensus standards and expected performance characteristics. Developers of devices on this list could use the new method to show substantial equivalence to a predicate device instead of conducting direct comparison to predicate as is currently done thereby reducing the burden of testing needed to get approval for their 510k. Traditionally, for 510k applications, developers need to show direct comparison to a predicate that may use a different technology, or may be much older device using antiquated systems that are challenging to test under current testing programs. In such cases, direct comparison is time-consuming and hard. Under the new program, instead of trying to compare to an older device, the manufacturer can simply show that their device performs at the levels relevant to its safety and effectiveness, and that it meets or exceeds those levels of performance for the characteristics established by FDA. To avail this option, the device must meet three criteria: (1) the new device’s indications for use and technological characteristics do not raise different questions of safety and effectiveness than the predicate, (2) the performance criteria align with the performance of one or more predicate devices, and (3) the new device meets the FDA required performance criteria. If a device cannot meet the performance criteria identified by FDA to demonstrate substantial equivalence, it can go back to direct performance comparisons against appropriate predicates under the Traditional 510(k) process. FDA’s staff will select existing performance criteria and test methodology or suggest new criteria that could support a finding of substantial equivalence based on their experience and expertise, literature, and analyses of data on existing devices within a device type. FDA reserves the right to make the determination of the appropriate standards. The overall structure of the abbreviated 510k application will be similar to the current format and will follow the same checklist. This program provides a convenient option to 510k device developers who struggle trying to directly compare a new device that is similar in intended use and biological effects but different in technological aspects to a predicate. The process will become clear as FDA start publishing the promised standards.