FDA cleared medium-risk medical devices that failed agency's own protocols: study

A new study published in JAMA has found the U.S. FDA has given the green light to moderate-risk medical devices despite them not always meeting the regulator’s own standards.

The so-called de novo premarket review pathway was set up all the way back in 1997 and acts as a way of clearing low-risk and moderate-risk medical devices. The idea is to lower hurdles for devices seen as less risky to speed up their arrival to the market.

Approval here can help devices clear the bar through the 510(k) pathway, which requires manufacturers to demonstrate that new devices are “substantially” equivalent to previously cleared devices.

But a team from Yale University found that almost 20% of moderate-risk, nonimplantable, nonlife-sustaining therapeutic devices cleared by the FDA through its pathway did not undergo a pivotal study.

The researchers also found, by sifting through publicly available data from the FDA, that more than one-third of the devices failed to meet at least one of the primary effectiveness criteria in their respective pivotal tests.

This is becoming more important given that use of the pathway has jumped in recent years: The FDA cleared 65 devices via this pathway between 1997 and 2012 but then went on to OK an additional 187 between 2013 and 2019.

“To ensure that better evidence is generated to guide clinical decision-making, the FDA could require that devices cleared through the de novo pathway meet prespecified effectiveness end points for clearance and that postmarket studies include larger patient populations,” James Johnston from Yale School of Medicine and colleagues wrote in JAMA Internal Medicine.

An FDA spokesperson, speaking to the Yale Daily News, said it does not comment on specific studies but rather “evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”