A draft guidance recently issued by the United States Food and Drug Administration (FDA) sets the stage for how an existing 510(k) pathway will be expanded with the goal of providing firms greater flexibility.
Guidance
The FDA published a draft guidance “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria” that provides the FDA’s proposed thinking on expanding the options for demonstrating substantial equivalence for premarket notification, called 510(k), submissions through the Abbreviated 510(k) program. The intent of the guidance is to describe a voluntary program for certain well-understood device types where, for the performance comparison aspect of substantial equivalence, a company would demonstrate that a new device meets FDA-identified performance criteria instead of directly comparing the performance of the new device to a specific predicate device.
The guidance, once finalized, could reduce regulatory burdens while maintaining standards for safety and effectiveness and providing patients and healthcare professionals with greater confidence that the device meets modern performance standards that reflect the complexity of more modern products. This approach could also facilitate health care professionals and patients making better informed decisions and give them greater confidence in the safety and effectiveness of devices cleared through this pathway because these devices would meet a transparent set of more up-to-date performance criteria.
“Manufacturers often rely on comparative testing against predicate devices to show that a new device is as safe and effective as a predicate device,” Gottlieb said. “But these predicates can be old, and in certain cases, they might not closely reflect the modern technology embedded in new devices.”
To address this issue, as reported by Regulatory Focus, the new option allows firms to avoid having to rely on whether a direct comparison to a predicate device can be demonstrated as part of a premarket submission.
Recent legislative actions, such as the 21st Century Cures Act of 2016, prompted the need for FDA policy clarifications in support of extending the “least burdensome” principles of the FD&C Act throughout the total product lifecycle to streamline regulatory decision making. The new draft guidance suggests the 510(k) alternative pathway is also being developed as part of these efforts.
Director at FDA’s Center for Devices and Radiological Health (CDRH), Jeff Suren, said last September the agency had attempted to include the new option under the latest reauthorization of industry user fees.