FDA Safety and Performance Based Pathway performance criteria

Sept. 30, 2019

The U.S. Food and Drug Administration (FDA) issued four draft guidances and updated a final guidance related to the Safety and Performance Based Pathway as part of our commitment to strengthening and modernizing the 510(k) program, as described in the FDA’s Medical Device Safety Action Plan.

The FDA also updated the Safety and Performance Based Pathway final guidance.

As a first step towards operationalizing of the Safety and Performance Based Pathway, the FDA issued four draft guidances that identify performance criteria and testing methodologies for certain devices within four class II device types:

·   Conventional Foley Catheters

·   Cutaneous Electrodes for Recording Purposes

·   Orthopedic Non-Spinal Metallic Bone Screws and Washers

·   Spinal Plating Systems

Read more at HPN.

This guidance provides FDA’s current thinking on expanding the concept of the Abbreviated 510(k) Program for demonstrating substantial equivalence for premarket notification (510(k)) submissions. The intent of the guidance is to describe an optional pathway – the Safety and Performance Based Pathway – for certain, well understood device types, where a submitter would demonstrate that a new device meets FDA-identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device.