by
Astrid Fiano, DOTmed News Writer | June 02, 2010
Medical devices are
the focus of public forum
The U.S. Food & Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is holding a public meeting June 24 to discuss public health needs through medical device development.
The public workshop will feature an open dialogue between the Council on Medical Device Innovation members and participants from public and private sectors. The purpose is to provide an opportunity to express what participants feel are priority areas in which medical devices can have the highest public health impact. In addition, the FDA is seeking comment on barriers to development and design of such devices that the federal government can minimize or remove. Participants can include industry, academia, patient or consumer advocacy groups, professional organizations and others.
The issues to be discussed include:
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-identification of the most important unmet public health needs
-the barriers to development, redesign, and access to medical devices for those needs, and
-the actions the federal government can take in removing/minimizing barriers
The Council on Medical Device Innovation consists of representatives from various federal agencies, including the National Institutes of Health, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality; the Department of Defense, the Defense Advanced Research Projects Agency, and the Department of Veterans Affairs. The Council's purpose is to focus on important public health needs and how medical devices address those needs. In particular, the council is considering which barriers to market and regulatory efficiencies are discouraging development of innovative devices.
The meeting will be held June 24, 2010, from 8:00 a.m. to 5:00 p.m., at the Hilton Hotel Washington, D.C. North/Gaithersburg, 620 Perry Pkwy Gaithersburg, MD 20877. Those wishing to attend need to register by close of business day on June 9. There is no fee. Those wishing to make oral presentations need to indicate that at the time of registration.
More on the workshop and registration forms may be found at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm212831.htm#registration
