FDA Unveils Framework for Safety, Performance-Based Pathway

The FDA has set out a framework how devicemakers will be able to demonstrate products are as safe and effective as a predicate device under an expansion of the agency’s abbreviated 510(k) pathway for certain, well understood device types.

The agency is soliciting feedback from industry on identifying performance criteria and testing methodologies for devices within four class II device types: spinal plating systems, cutaneous electrodes for recording purposes, conventional Foley catheters, and orthopedic non-spinal metallic bone screws and washers.

The safety and performance-based pathway is appropriate when FDA has determined that:

• The new device has indications for use and technological characteristics that don’t raise different questions of safety and effectiveness than the identified predicate;
• The performance criteria align with the performance of one or more legally marketed devices of the same type as the new device; and
• The new device meets all the FDA-identified performance criteria.

Devicemakers will still need to identify a predicate device for certain aspects of substantial equivalence, but instead of conducting direct comparison testing, they will be able to use the safety and performance-based pathway.

Read the agency’s notice here: www.fdanews.com/09-26-19-Framework.pdf.