Institute of Medicine Holds First 510(k) Public Workshop

The Institute of Medicine’s (IOM) first public workshop to address the effectiveness of the 510(k) review process was held in Washington, DC, and had a large attendance.

Dr. Josh Makower, MDMA member and CEO of ExploraMed, testified before the panel and highlighted the current challenges innovators face while developing products.  Dr. Makower noted that according to a recent PricewaterhouseCoopers report, VC funding in the medical device field dropped 29% from Q4 2009 to Q1 2010.  He discussed how countless exciting breakthroughs are being made in incubators throughout the country, but that policy makers must ensure that a predictable and transparent environment exists to stimulate investments for improved patient care and innovation.

MDMA will continue working with the IOM as they analyze the 510(k) process, and encourages you to share your concerns with us so we can ensure they are being heard by policy makers.