FDA Proposes New Option for Device Companies to Apply for 510(k) Clearance

Regulatory NewsRegulatory News | 11 April 2018 |  By 

A draft guidance the US Food and Drug Administration (FDA) revealed Wednesday sets the stage for how an existing 510(k) pathway will be expanded with the goal of providing firms greater flexibility.

By expanding the previously established Abbreviated 510(k) program, the new option will “modernize the FDA’s approach to moderate risk devices by allowing manufacturers to use objective performance criteria to facilitate demonstration of substantial equivalence of their new products to legally marketed devices,” FDA Commissioner Scott Gottlieb said in a statement.

FDA intends to support the iterative nature of certain new devices for which performance criteria are well understood via the new option—aimed at reducing administrative burden and expediting review processes. This speaks to the goal FDA set earlier this year to bring more than 50% of manufactures of novel technologies to the US market first or in parallel with other countries by 31 December 2020.

“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, 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 The new draft guidance suggests the 510(k) alternative pathway is also being developed as part of these efforts.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.

The draft guidance provides details on which devices would be considered appropriate for the new option based on intended use and technological characteristics, how FDA intends to identify performance criteria for the purposes of making final substantial equivalence determinations, as well as what the expectations are for device makers submitting data for FDA review via this program.

For example, the agency said it “expects a submitter to demonstrate that the new device meets the FDA-identified performance criteria by submitting a declaration of conformity, a summary of the data, and/or underlying data, as appropriate.”

Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria


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