One of the big points of contention between industry and FDA is the difficulty in getting the agency to approve investigational device exemptions, but the recent guidance on early feasibility studies is intended to ease the logjam at the point of first-in-human (FIH) studies. Several members of the FDA staff appeared at CRT 2012 to discuss the guidance, but the fact that many devices have already been introduced in other nations led to some questions as to why the agency can't be less restrictive without the need for a focused guidance. Read More
