As a first step toward implementation of its recently established Safety and Performance Based Pathway for medical devices, FDA is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices:
Conventional foley catheters.
Cutaneous electrodes for reporting purposes.
Orthopedic non-spinal metallic bone screws and washers.
Spinal plating systems.
“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,” says Jeff Shuren, MD, director of the FDA’s CDRH.
“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. 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.”
Shuren says that 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 that a new device is substantially equivalent to devices already on the market.
“This ensures patients have timely access to beneficial products. This new approach may also drive greater market competition to develop safer, more effective devices by providing the opportunity to demonstrate superior performance to the FDA-established benchmarks,” he says.
Devices being reviewed and cleared under this new pathway must still meet regulatory requirements for safety and effectiveness; however, FDA says it expects this pathway to promote a competitive marketplace for developing even safer, more effective technologies, giving patients timely access to more beneficial medical devices.
These first four device-specific guidances were chosen because for these device types, the agency had already worked to develop performance criteria and/or FDA-recognized consensus standards exist for the performance of these devices. The agency is soliciting 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.
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