FDA Unveils Safety and Performance 510(k) Pathway

The FDA released details of its Abbreviated 510(k) review process, which it has renamed the Safety and Performance Based Pathway.

Last April, the FDA issued draft guidance proposing an expanded abbreviated 510(k) clearance program that would allow companies to show a new product’s substantial equivalence to an existing device using performance criteria rather than directly comparing the device’s performance to a predicate device.

Almost 20 percent of current 510(k) clearances are based on predicates that are more than a decade old, and the agency wants to promote the use of more modern predicates in order to compare devices to newer technology.

The final guidance, released on Jan. 22, focuses on the substantial equivalence analysis that requires a 510(k) submitter to demonstrate that its device is as safe and effective as a legally marketed device. Under the program, if a predicate device meets performance criteria for safety and effectiveness and a new device meets or exceeds the same levels, the agency could deem the device as safe and effective as the predicate instead of requiring a direct comparison (IDDM, April 13, 2018).

The final guidance expands the concept of the Abbreviated 510(k) program by explaining how substantial equivalence for certain device types may be demonstrated in a way that is “less burdensome, but at least as robust.” The approach may also make the review of 510(k) submissions more efficient, reducing burdens on the agency and possibly review times for individual submissions.

Keeping Pace With Innovation

“[O]ne of our goals is to ensure that the 510(k) program is keeping pace with the important innovations we’re seeing in device development,” said FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren in a joint statement. “We believe this means that, where appropriate, new medical devices coming to market under the 510(k) pathway should either account for advances in technology that can improve the safety or performance of these products, or demonstrate that they meet more modern safety and performance criteria.”

The new pathway “will modernize our approach to moderate risk devices by allowing manufacturers to use objective performance criteria established or recognized by the FDA to facilitate demonstration of substantial equivalence of their new products to legally marketed devices,” Gottlieb and Shuren said.

The new pathway will ensure that the performance characteristics of new devices are evaluated against a set of objective, transparent and well-validated safety and performance metrics, the agency said.

The FDA is soliciting public comment on the guidance until April 22.

Read the final guidance here: www.fdanews.com/01-31-19-Pathway.pdf.