New 510(k) Pathway Could Lead to Shorter Review Times, Experts Say

The FDA’s new Safety and Performance Based Pathway for 510(k) applications should be less burdensome than the longstanding Abbreviated 510(k) route to market, according to attorneys at the law firm King & Spaulding.

The new pathway provides increased certainty regarding the likelihood of clearance for qualifying devices, said Elaine H. Tseng and Quynh Hoang, senior regulatory consultants at the firm.

The agency intends to identify the types of devices that qualify for Safety and Performance Based Pathway review, as well as, for each such device, the full set of performance characteristics and associated performance criteria that must be shown to achieve clearance.