FDA publishes first device-specific safety and performance pathway guidelines

More than two years after the US Food and Drug Administration (FDA) first proposed an alternate safety and performance based pathway for certain well-understood medical devices, the agency has finalized the first two device-specific guidelines establishing performance criteria to support 510(k) clearance via the new pathway.

The two final guidelines provide performance criteria for cutaneous electrodes for recording purposes and conventional foley catheters.

While the established 510(k) pathway requires device makers to demonstrate substantial equivalence to a predicate device, FDA says the new optional safety and performance based pathway builds on its Abbreviated 510(k) program to give device makers the flexibility to use performance criteria and voluntary consensus standards, rather than direct comparison testing against a predicate device to support 510(k) clearance.

“If a legally marketed device performs at certain levels relevant to its safety and performance for the same characteristics, FDA could find the new device as safe and effective as the legally marketed device. Instead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence with data demonstrating the new device meets the level of performance of an appropriate predicate device,” FDA writes.