U.Va. to Host FDA Workshop for Medical Device Developers

September 14, 2011

September 14, 2011 — The University of Virginia will co-sponsor a U.S. Food and Drug Administration workshop on medical device innovation, regulation, device education and translational research on Sept. 26 in Jordan Hall.

The full-day workshop is part of the FDA's Medical Technology Innovation Partnerships Project, now in its second year. The goal is to enhance the U.S. regulatory process through proactive collaboration with U.S. research universities and emerging entrepreneurs. U.Va. has been a lead partner on the initiative from the start.

"U.S. medical innovation is one of the last great American industries," said Thomas C. Skalak, U.Va.'s vice president for research. "To help preserve our ability to produce useful new medicines and devices, the FDA is now proactively seeking to collaborate with the research engines of the U.S., which are our research universities. By coupling regulatory concerns with the earliest stages of new R&D work in university labs, we may be able to accelerate the development of cost-effective health care for all people. This meeting is a harbinger of a new era of collaboration among research universities as early-stage innovators, the corporate world that produces and delivers products, and the government leaders who help guide and verify safety and efficacy."

The workshop's clinical focus will be emerging technologies in personalized cancer diagnostics and cardiovascular device development. "These are areas the FDA has identified where increased collaboration with the academic researcher and more transparency in the regulatory process can have great impact," said David Chen, U.Va.'s director of translational research.

Fifteen staff members from the FDA's Center for Device and Radiological Health, including division directors, inspectors and network leaders, will be on hand to collaborate with researchers, entrepreneurs, technology transfer offices and students. Afternoon breakout sessions will cover the regulatory process from first communication through clinical study design. The day will conclude with a discussion of a National Medical Device Development Curriculum. A complete agenda is available online.

This event is free of charge. To attend, contact Angel Thompson at angelt@virginia.edu.

— By Dan Heuchert

Media Contact

Dan Heuchert

Assistant Director of University News and Chief Copy Editor, UVA Today Office of University Communications