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<key-projects><projects><title>Foster the Development of Medical Devices to Respond to Unmet Public Health Needs</title><description>Identify important unmet public health needs and work with our federal government partners and external constituencies to take steps to reduce these barriers. Unmet public health needs are defined as illnesses and injuries that: (i) are serious or have a moderate adverse impact on health but affect many individuals; (ii) could be cured, significantly improved, or prevented by the development or redesign of a device; and (iii) the device(s) is not being developed or redesigned due to barriers that the federal government can directly or indirectly remove or minimize.</description><dictionary></dictionary><outcome></outcome><accomplishment>The Council on Medical Device Innovation, comprised of eight federal government partners, convened a public workshop in June 2010 to identify areas of unmet public health need that could be addressed through medical device and/or radiation emitting products. The five areas identified in 2010 included two settings, wireless health care and home use of devices, and three medical targets, diabetes, spinal cord injury, and cancer.  To solicit innovative solutions to one of the identified unmet public health needs, diabetes, CDRH and the Defense Advanced Research Projects Agency (DARPA) are holding a workshop on February 9, 2011 (see &lt;a href=http://www.federalregister.gov/articles/2010/12/20/2010-31811/defense-advanced-research-projects-agency-and-food-and-drug-administration-expanding-in-vivo#p-1431_bank”&gt;FR notice&lt;/a&gt;).  The workshop will focus on the technical challenges for developing implanted or continuously applied devices capable of measuring and monitoring clinically relevant molecular biomarkers (small molecules, proteins, peptides, and nucleic acids) to alert the user of the need for clinical attention and/or to inform the clinician with regard to appropriate action.</accomplishment><table><title></title><overall-status><briefing></briefing><prior-briefing></prior-briefing></overall-status><row><type></type><milestone-description>A. Establish a Council on Unmet Public Health Needs (Council) composed of participants from federal agencies</milestone-description><milestone-date>3/31/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>3/31/2010</milestone-completion-date></row><row><type></type><milestone-description>B. Hold one or more public workshops to identify the most important unmet public health needs and the barriers to the development of medical devices that can cure, significantly improve, or prevent these illnesses or injuries</milestone-description><milestone-date>6/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>6/24/2010</milestone-completion-date></row><row><type></type><milestone-description>C. Hire a medical device innovation coordinator</milestone-description><milestone-date>7/31/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>11/30/2010</milestone-completion-date></row><row><type></type><milestone-description>D. Identify feasible, high return-on-investment options to solicit innovative solutions to unmet public health needs from external constituencies</milestone-description><milestone-date>9/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>9/30/2010</milestone-completion-date></row><row><type></type><milestone-description>E. Identify key agency staff who will devote at least part of their time to medical device innovation and establish roles and responsibilities</milestone-description><milestone-date>9/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>9/30/2010</milestone-completion-date></row><row><type></type><milestone-description>F. Identify the steps the federal government can realistically take to remove or minimize barriers to the development of devices that respond to two or more of the top five most important unmet public health needs.</milestone-description><milestone-date>9/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>9/30/2010</milestone-completion-date></row><row><type></type><milestone-description>G. Implement one to two of the identified high return-on-investment options to solicit innovative solutions to unmet public health needs from external constituencies across all devices or for specific types of devices.</milestone-description><milestone-date>9/30/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>10/31/2010</milestone-completion-date></row><footnotes><note></note></footnotes></table></projects><glossary></glossary><related-links><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm203038.htm</url><text>FDA-TRACK CDRH Dashboard</text></link></related-links></key-projects>਍††਍਍਍਍਍਍਍