FDA Overhauls Medical Device Approval Process

The FDA has announced that it is overhauling its system for approving medical devices. Under the current system, a manufacturer can rely on the safety information from similar products already on the market, which has led to companies using information from devices that were tested decades ago. The FDA’s announcement comes on the heels of investigative journalism reports that revealed how the expedited approval process has harmed many consumers. The reports, along with decades of experts’ criticisms, have prompted the FDA to reconsider its practices, and the agency has proposed to make public when a company relied on safety information from products created ten or more years ago. Well over half of the medical devices on the market were approved using the current process, which has been in place since 1976, when the FDA began monitoring medical devices. The agency hopes this overhaul will promote innovation among product manufacturers and lead to safer devices for consumers. 

The announcement comes on the heels of a publication by the International Consortium of Investigative Journalists (ICIJ) about the deaths related to medical devices. In fact, data revealed by ICIJ found that there were more than 80,000 deaths and 1.7 million injuries linked to medical devices since 2008. (Source: https://www.icij.org/investigations/implant-files/what-you-need-to-know-about-the-implant-files/.)  Furthermore, the number of injuries has risen steadily over the past decade – with just above 50,000 reported in 2008 to more than 275,000 medical device related injuries reported by the FDA in 2017.  Hopefully the FDA will revamp the  approval process so that only the safest, most effective medical devices make their way to consumers and patients.