Non-spinal metallic bone screws and washers and, spinal plating systems have been identified in draft guidances by the FDA as two of four devices to qualify for the agency’s expedited Safety and Performance Based Pathway for medical devices program.
That means makers of these devices, if they chose to participate in the program, will no longer have to show side-by-side performance assessments with a predicate device. The makers will only have to show equivalence or superiority through safety and performance criteria set by the FDA.
The other two types of devices identified for the program are conventional Foley catheters and cutaneous electrodes for reporting purposes.
On September 19, 2019, the agency said it will evaluate devices in this program against a set of FDA-identified objective and transparent metrics consistent with the safety and performance characteristics of modern predicates.
Benchmarking Modern Tech Against Modern Standards
The FDA’s device chief, Jeff Shuren, M.D., said the major benefit is that the pathway “will benchmark modern technology against modern standards while, at the same time, offering a potentially more efficient way to demonstrate a new device is substantially equivalent to devices already on the market.”
“This new option for 510(k) clearance of certain well-understood device types will allow manufacturers to use objective performance criteria—established or recognized by the FDA—to demonstrate substantial equivalence of their new products or superior performance to those already legally on the market.”
Shuren is the director of the FDA’s Center for Devices and Radiological Health.
The FDA said it chose to release these first four device-specific guidances because it had already developed performance criteria for them, or FDA-recognized consensus standards exist for the performance for these type of devices.
The FDA is asking for public feedback on these guidances, which will assist in the finalization of the initial device-specific guidances and also aid in expansion of the pathway to other types of medical devices in the coming months.
In addition to publishing the draft guidances, the FDA also updated the Safety and Performance Based pathway guidance issued in February 2019 to further clarify the information the FDA will review in a 510(k) using the Safety and Performance Based Pathway.
You can study the four draft guidances here.
