With an increasing number of companies seeking to get medical devices on the market and drug makers hoping to formally register an ever-expanding list of biomarkers to more effectively gauge clinical trial outcomes, the US Food and Drug Administration released preliminary rules on its website on Monday (August 15) that will govern both processes.
The guidelines for device makers are extensive and detail the factors the FDA considers when making risk-benefit determinations during the pre-market approval (PMA) process for medical devices. The agency lists several aspects of effectiveness and safety that device makers should consider when testing particular medical devices. The document, which the FDA refers to as a "draft guidance," also provides a handful of hypothetical devices and illustrates how the agency might handle approval given specific safety and efficacy data gathered for each.
"As medical devices grow increasingly complex, many factors impact our benefit-risk determinations," Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. "This guidance aims to provide more clarity to manufacturers about what factors we consider when making an approval decision."
The other draft guidance released by the FDA instructs drugmakers on how best to go about qualifying genomic biomarkers with the agency, such that their use in clinical trials is considered an accurate reflection of biological processes, responses, or events among patients. The guidelines spell out exactly what a qualification application should contain, including detailed data reports, the context in which the marker is meaningful, and full descriptions of the studies supporting its use.
The public now has 90 days to offer comments on both sets of proposed rules.