The U.S. Food and Drug Administration (FDA) has proposed a new pathway for vendors to receive 510(k) clearance for certain moderate-risk devices.
In a draft guidance, the FDA shared details on a new voluntary option that would allow vendors to demonstrate substantial equivalence of certain new products to legally marketed device types by meeting performance criteria from "well-understood device types." Currently, manufacturers often rely on comparative testing against predicate devices to show that a new offering is as safe and effective. However, these predicate devices may be old, and in some cases they might not closely reflect the modern technology embedded in new devices, according to the FDA.
Instead of direct comparisons with a predicate device, the FDA said it could now support a finding of substantial equivalence based on data showing the new device meets or exceeds the level of performance that is consistent with the performance profile of an appropriate predicate device. These criteria could include FDA-recognized consensus standards as well as criteria established by FDA guidances, according to the agency.
"By allowing a set of objective, transparent, and well-validated performance metrics to serve as the benchmark for evaluating some new devices, this new pathway offers a more efficient and less burdensome option to demonstrate that certain new devices are substantially equivalent to ones already on the market," said FDA Commissioner Dr. Scott Gottlieb in a statement.
Once finalized, the guidance could reduce regulatory burdens while maintaining standards for safety and effectiveness, the FDA said. In addition, patients and healthcare professionals could have greater confidence that the device meets modern performance standards that reflect the complexity of more modern products, according to the agency.
