FDA Makes Progress on Safety and Performance Based Pathway


Posted September 24, 2019

As part of its efforts to modernize the 510(k) program, the Food and Drug Administration (FDA) has published four draft guidances and updated a final guidance document related to the Safety and Performance Based Pathway. The agency previously stated that it expects to operationalize the pathway "once the first device types and applicable performance criteria have been identified and final guidances have been published."

In the context of "certain, well understood device types," the Safety and Performance Based Pathway is an option for submitters to "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," wrote the agency.

Further, the FDA said that the Safety and Performance Based Pathway builds on the approach used in the Abbreviated 510(k) Program. Manufacturers submitting an Abbreviated 510(k) leverage "conformity to FDA-recognized consensus standards, FDA guidance, and/or special controls to demonstrate some of the performance characteristics necessary to support a finding of substantial equivalence," the agency stated in the guidance.

In a similar vein, the Safety and Performance Based Pathway entails the use of "robust versions of those same mechanisms, which contain all the performance characteristics necessary to support a finding of substantial equivalence for a device type, rather than using direct predicate comparison testing to support a finding of substantial equivalence for some of the performance characteristics."

As part of its effort to operationalize the Safety and Performance Based Pathway, the FDA issued four draft guidances detailing 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, and Spinal Plating Systems.

The 90-day period for public commenting on the four draft guidances began on Sept. 19. Comments can be submitted at www.regulations.gov using docket numbers FDA-2019-D-1651 (Foley Catheters), FDA-2019-D-1649 (Cutaneous Electrodes), FDA-2019-D-1652 (Orthopedic Non-Spinal Metallic Bone Screws and Washers), and FDA-2019-D-1647 (Spinal Plating Systems).

On Nov. 7, the agency will host a webinar to discuss these Safety and Performance Based Pathway guidance documents.