The ACC has secured representation at a somewhat historic meeting of the regulatory pharma-device agencies of the EU, UK (NICE), and US (FDA) in France on Jan 27-28, 2011. Mitch Krucoff, MD, FACC, of Duke, and Doug Weaver, MD, MACC, of Henry Ford, are our representatives. The idea is to collaborate on these efforts and speed up approvals and innovation of new cardiovascular technological advancements. In addition, its goals are to establish:

• General principles of clinical efficacy and patient safety for the use of diagnostic and therapeutic devices in cardiovascular medicine
  
  
• Recommendations for the clinical evidence (criteria) and systems that should be required by regulatory authorities before granting approval to new devices in cardiovascular medicine
  
  
• Recommendations for the monitoring of the performance of medical devices after they have been granted regulatory approval

A meeting with such an esteemed panel of representatives from these major agencies has never occurred before. Lessons learned from this conference with our European colleagues should be very helpful for the FDA and the U.S. cardiovascular community to become more forward-thinking in the diffusion of innovative CV technology while at the same time not relinquishing our well-known high standards for safety and efficacy evaluations of such. With Dr. Krucoff’s expertise with his leading role in FDA’s Critical Path Initiative and Dr. Weaver’s role as past president of the ACC and chair of the CathPCI NCDR steering committee, we indeed are well represented.