CDRH Takes First Step to Operationalize New Safety and Performance Based Pathway
Posted 19 September 2019 | By
As part of work to implement the optional Safety and Performance Based Pathway for medical devices, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday issued four draft guidance documents identifying performance criteria and testing methodologies for certain devices within four class II device types.
CDRH also released updated final guidance
explaining the new pathway and to further clarify the information FDA will review in a 510(k) using the Safety and Performance Based Pathway.
CDRH allows three types of 510(k) submissions: Traditional
. The Special and Abbreviated 510(k) programs were developed in 1998 and described in the "New 510(k) Paradigm," which facilitates the review process for certain types of submissions subject to 510(k) requirements.
In 2019, FDA split this “New 510(k) Paradigm” into separate guidance documents: The Special 510(k) Program
and the Abbreviated 510(k) Program
. The Safety and Performance Based Pathway is an expansion of the concept of the abbreviated pathway
for certain, well understood device types.
The idea for expanding CDRH’s Abbreviated 510(k) program, first proposed in April 2018
, was centered on providing additional flexibility for eligible device types to seek 510(k) clearance through increased use of device performance criteria and voluntary consensus standards rather than direct comparison testing of predicate devices.
FDA said that it expects to operationalize this pathway once the first device types and applicable performance criteria have been identified and final guidances have been published.
All four of the short draft guidance documents offer information on what specific devices are subject to each guidance, as well as the testing and performance criteria. The guidances cover spinal plating systems, cutaneous electrodes for recording purposes, conventional foley catheters and orthopedic non-spinal metallic bone screws and washers.
“For example, if a manufacturer wants to market a new spinal plating system that falls within the scope of the guidance, with this new pathway, they would submit a 510(k) demonstrating that the safety and performance characteristics of their device are consistent with the new FDA-identified criteria. They would not need to provide a side-by-side performance assessment with a predicate device,” CDRH Director Jeff Shuren said.
Industry also may suggest other device types for which FDA should consider identifying performance criteria.
“For example, industry may suggest devices for which there are comprehensive FDA-recognized consensus standards. We encourage industry and other stakeholders to submit evidence-based suggestions on what the performance criteria should be for eligible device types,” FDA said.
Framework for the Safety and Performance Based Pathway
Spinal Plating Systems
Cutaneous Electrodes for Recording Purposes
Conventional Foley Catheters
Orthopedic Non-Spinal Metallic Bone Screws and Washers