FDA device chief, Jeff Shuren, is in complete denial regarding the effects of the Agency on innovation

FDA device chief Shuren: Recession played a role in pushing medical device industry to EU (MassDevice)

The “Device Gap” between EU and US is heating up

Jeff Shuren testified at a House Oversight & Government Reform Subcommittee on Health Care’s “Pathway to FDA Medical Device Approval: Is there a Better Way?”

1. Shuren believes that the recession created a more “risk-averse” investment environment that helped push medical device companies to launch in Europe, rather than its relatively easier path to market clearance.
2. Shuren believes that only 10% of cost of bringing a new device to market is FDA related rather than 75% stated in the Standford University Study.
3. Shuren believes that the US regulatory system is better than the EU regulatory system.