Medical Device Regulation in US Needs Improvement, Stanford Review Says
January 21st, 2008 joshua
The Stanford University Program in Biodesign seeks a way to improve the regulation and reporting of new medical devices to consumers. It recently published an article in the December 2007 issue of Journal of Medical Devices.
According to the report, the major hurdles faced in getting a new device from the lab to the patient stems from “the lack of precise scientifically based data about testing, regulatory approval and health-economic evaluation processes.”
The goal of the study is to foster an environment where medical device regulation is up to par with the prescription drug industry. Unfortunately, those regulations too often are at the mercy of a lobbyist, not the merits of the drug itself.
Another goal is to allow patients with an implanted device or those weighing that option more information to reports on the device.
Devices are classified by risk into three categories. Class I devices such as gloves aren’t regulated much at all, while Class II and III devices carry an implied risk, since the devices are classified according to risk.
