Medical Devices to Get Speedier Approvals With FDA Guidance

Medical device makers that can show their new gadgets meet the FDA’s standards of safety, efficiency, and performance by comparing them to older devices could get speedier approval under a final guidance published Jan. 22.

The Food and Drug Administration guidance contains nonbinding standards for its newly named Safety and Performance Based Pathway. It’s an “abbreviated” version of the agency’s 510(k) pathway program—the most used method for clearing mid- to low-risk devices that relies on comparisons to similar products already on the market, known as predicate devices.

The new abbreviated pathway is one of three types of approval pathways under ...