FDA Cleared Some Moderate-Risk Devices Without Pivotal Studies, Study Finds

A study assessing the FDA’s De Novo premarket review pathway found that some devices received clearance without supporting data from pivotal clinical trials.

The De Novo process allows FDA to classify new devices that are not equivalent to an existing Class I or Class II device and would otherwise be automatically classified as a Class III high-risk device.

The Yale University study, which was published in the Journal of the American Medical Association, found that the FDA cleared 65 moderate-risk, nonlife-sustaining devices through the premarket review pathway between 2011 and 2019, granting clearance to 12 devices (19 percent) that weren’t evaluated through pivotal studies.

Of the devices that did go through pivotal trials, 31 percent failed to meet at least one primary efficacy endpoint, but the devices still earned clearance, the researchers found.