FDA device chief, Jeff Shuren, is in complete denial regarding the effects of the Agency on innovation
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?”
- 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.
- 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.
- Shuren believes that the US regulatory system is better than the EU regulatory system.