W. Gregory Shearer – June 30, 2016
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.
Currently, companies in the United States that want to sell high-risk devices, such as implants designed to support and sustain life, must first demonstrate that their products are reasonably safe and effective — usually through clinical trials.
In the European Union, by contrast, medical devices can be sold as long as they perform “as intended” and “are likely to be safe.” They generally get to market faster than in the US.
In the new study, published Tuesday in the BMJ, researchers found that medical devices that were first approved in the European Union were associated with a greater rate of safety issues than devices first approved by FDA.
Researchers examined 309 devices, 206 of which were approved by the FDA and the EU. Sixty-three percent were approved first in the EU.