FDA Issues First Final Guidances on New 510(k) Pathway

Conventional Foley catheters and cutaneous electrodes are the first two types of devices to get their own final guidances under the FDA’s new safety and performance-based pathway for 510(k) marketing clearance.

The documents specify what performance criteria sponsors should provide to the agency under the abbreviated 510(k) device clearance program, instead of the traditional comparisons to predicate devices.

The aim of the new clearance pathway is to reduce the regulatory burden on sponsors. In some cases, the agency said, it may be more burdensome for a submitter to compare the product to a  predicate device than to demonstrate that the device meets safety and performance criteria established by the FDA.