There’s been plenty of talk over the years about the FDA being broken—its review process is too slow, its decisions flawed, its costs too high. The talk has come from industry, the public, and academia. The catalyst has been frustration.
The makers of medical devices must wait for the FDA to decide whether a device is “substantially equivalent” to one already on the market when clearing a device through the 510(k) process, or “safe and effective” when shepherding a device through the premarket approval process. This can take weeks to months under 510(k) or years under the more rigorous premarket approval process. User fees paid by industry to support these reviews will total nearly $300 million from 2008 to 2012, according to an industry estimate.