FDA Report Card 2015

The relationship between FDA and the medtech industry seems to have been improving in recent years, but in which areas is the agency getting better? We asked a panel of regulatory experts to grade FDA's performance in everything from transparency and consistency to implementation of the unique device identification system. The panel members were:

• Vicki Anastasi, global head of medical device and diagnostics research, ICON 
• Michael Drues, PhD, president, Vascular Sciences
• Gordon MacFarlane, PhD, RAC, senior regulatory affairs manager, ICON
• Larry R. Pilot, attorney at law
• Jeffrey K. Shapiro, Director, Hyman, Phelps & McNamara
• Bradley Merrill Thompson, shareholder, Epstein Becker & Green

Here's how the regulator stacked up.