WASHINGTON — Medical device companies have argued that streamlining the regulatory process at the Food and Drug Administration could help get their devices onto market more quickly and ultimately help save lives.
But a new study comparing US and European approaches to medical devices suggests that doing so could also carry significant risks for patient safety.
The two-continent study — led by Harvard Medical School researchers — comes as Congress is considering legislation that would make it easier to get drugs and medical devices through the regulatory process.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
To submit a correction request, please visit our Contact Us page.
