FDA Report Card 2015: Review Times

Review Times

On one hand, review times are important for planning purposes. On the other hand, is it more important to have a fast decision or a correct one? In many cases, people’s lives are at stake, and proper reviews take time. How about a discussion of how long it takes for a company to develop a device prior to regulatory submission? Regrettably, in both companies and the FDA, the inefficiencies can be staggering.

—Michael Drues, PhD, president, Vascular Sciences

Since the enactment of the Medical Device Amendments of 1976 and subsequent amendments which identified explicit performance dates, the FDA/CDRH has rarely been able to meet objectives.

—Larry R. Pilot, attorney at law

FDA seems to be hitting the majority of its user fee deadlines. But honestly I view those user fee deadlines as the minimum requirement, and I would hope FDA would exceed them.

—Bradley Merrill Thompson, shareholder, Epstein Becker & Green