Enhance epidemiological assessment of medical device performance by establishing an extramural collaborative network with ten leading academic institutions that have experience with medical device studies. The ultimate long-term goal is to substantially contribute to the understanding of medical device performance and CDRH decision making, thereby improving public health, with a shorter term focus on building a research infrastructure by linking CDRH with leading academic organizations in the country that have experience with medical device studies. ON TRACK ON TRACK A. Establish MDEpiNet Partnership Development Team to develop a research plan 2/28/2010 Completed 2/28/2010 B. Hold kickoff workshop with academic stakeholders 4/30/2010 Completed 4/30/2010 C. Award the contract for administration of MDEpiNet 9/30/2010 Completed 9/30/2010 D. Award contracts for 3-4 pilot projects to MDEpiNet academic centers 9/30/2010 Completed 9/30/2010 E. Establish formal partnerships with MDEpiNet academic centers 12/31/2010 Completed 12/31/2011 F. Receive 1st Quarterly Report (all pilot projects) 12/31/2010 Completed 12/31/2010 G. Receive 2nd Quarterly Report (all pilot projects) 3/31/2011 Completed 3/31/2011 H. Receive 3rd Quarterly Report (all pilot projects) 6/30/2011 Completed 6/30/2011 I. Receive final report (all pilot projects) 9/30/2011 Completed 9/30/2011 J. Evaluate the success of the MDEpiNet Program 12/31/2011 Completed 12/31/2011 K. Launch a dedicated website for MDEpiNet on fda.gov domain 6/30/2012 Completed 4/3/2012 L. Hold a public workshop inviting stakeholders to discuss MDEpiNet accomplishments and future directions 6/30/2012 <i>(9/11/2012) Completed 9/11/2012 M. Award cooperative agreement(s) to support MCM-priority projects 9/30/2012 Completed 9/11/2012 N. Publish a partnership charter detailing operations of MDEpiNet and roles and responsibilities of all partners, including FDA (1) N/A Not Completed N/A O. Issue a request for information (RFI) soliciting feedback on how to structure and run the MDEpiNet Partnership 12/31/2012 Completed 12/11/2012 P. Meeting of MDEpiNet Advisory Committee to obtain input on structure, governance and scientific plans for MDEpiNet 3/7/2013 On Track (1) Milestone N has been retired and replaced by Milestone O as the project took a new direction. http://www.fda.gov/AboutFDA/Transparency/track/ucm203038.htm FDA-TRACK CDRH Dashboard http://www.youtube.com/watch?v=uqdgOQ8BzT0&feature=player_profilepage Watch the Video: FDA's MDEpiNet - Improving Medical Device Safety and Effectiveness http://www.fda.gov/MedicalDevices/ScienceandResearch/EpidemiologyMedicalDevices/MedicalDeviceEpidemiologyNetworkMDEpiNet/default.htm MDEpiNet Home Page ਍††਍਍਍਍਍਍਍