The FDA has released draft guidances for the first four types of devices it will evaluate under its expedited Safety and Performance-Based Pathway to 510(k) clearance. They are:
- Conventional foley catheters.
- Cutaneous electrodes for reporting purposes.
- Orthopedic non-spinal metallic bone screws and washers.
- Spinal plating systems.
Developers of these types of devices will no longer need to provide the FDA with a side-by-side performance assessment with a predicate device. They will only need to demonstrate that their device is equivalent or superior through certain safety and performance criteria set by the agency.
Devices reviewed under this new pathway must still meet regulatory requirements for safety and effectiveness. The agency said it expects this pathway to boost competition and give patients more timely access to modern devices.
“One of our goals with the Safety and Performance-Based Pathway is to ensure that the 510(k) program is keeping pace with the important innovations we’re seeing in device development. This new pathway reflects our focus on advancing new products that are safer and more effective,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a news release. “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.”
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.
The agency also 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 seeking public feedback on these guidances to help it complete the initial device-specific guidances and expand the pathway to other types of devices in the coming months.
The FDA also updated the final guidance on the overall Safety and Performance-Based Pathway new 510(k) program it announced in February 2019 to further clarify the information it will need for the new review process.