AAMI News January 2018

FDA Commits to Modernizing Reviews, Promoting Innovation in 2018

The Food and Drug Administration (FDA) says it will step up its efforts to modernize the review process for medical devices, placing a greater emphasis on the use of postmarket data and relying more on international standards to help evaluate products in 2018.

“FDA’s regulatory process has remained largely unchanged since it was first implemented 40 years ago,” FDA Commissioner Scott Gottlieb wrote in a blog post. “As a consequence, there are an increasing number of cases where this basic framework isn’t well-suited to reflect the innovation that we see today in certain technologies and how we must evaluate those technologies.”

Modernizing 510(k) Review

During the first quarter of 2018, the FDA plans to publish draft guidance that will outline a voluntary pathway for demonstrating “substantial equivalence” for devices that would have previously been cleared through the 510(k) pathway. Using the new alternative pathway, manufacturers would be able to demonstrate “substantial equivalence” by meeting safety and performance criteria found in FDA-recognized standards and/or published guidance documents.

“This pathway would be available for pre-specified categories of mature devices—those for which safety and performance criteria that meet or exceed the performance of existing, legally marketed devices can be identified,” Gottlieb explained. “This approach will also make it easier for FDA to conform its framework for evaluating new products to international consensus standards where such standards exist.”

Gottlieb provided the examples of ultrasound imaging machines, common in vitro diagnostic devices, and blood pressure monitors.

Balancing Pre- and Postmarket Requirements

The second draft the FDA intends to publish early this year will outline how the agency decides when it’s appropriate to “place greater reliance on postmarket data” when determining whether the probable benefits of a device outweigh any potential safety risks.

“The guidance will outline how certain issues could be ultimately resolved in the postmarket setting, rather than the premarket setting, to allow patients to gain faster access to potentially life-saving devices, when appropriate,” Gottlieb added. This approach to evaluating uncertainty could be used in any of the existing pathways the FDA uses to clear new devices—510(k), de novo, premarket approval, or humanitarian device exemptions.