This project proposes the development of a new, more efficient, effective, and focused collaborative effort to share information, experiences and develop strategies that improve medical device safety amongst regulatory systems tasked with responsibilities unique to global medical device regulators. This plan seeks to establish mechanisms to facilitate regulator-to-regulator organization and governance structure to facilitate exchange of information, sharing of best practices, provide opportunities to identify commonalities and develop approaches to regulatory barriers that, in the past, prohibited the implementation of global strategies. Final guidance on the Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot program was issued on March 19, 2012. CDRH began the pilot program on June 5, 2012. A. Draft a plan for establishing a device regulators forum. 9/30/2010 Completed 9/30/2010 B. Propose and discuss the draft plan with heads of agencies from GHTF founding countries. 10/31/2010 Completed 10/31/2010 C. Propose and discuss the draft plan with regulators on the GHTF's Steering Committee. 11/30/2010 Completed 11/30/2010 D. Begin to organize the international heads of device programs meeting, to be held in the U.S. 12/31/2010 Completed 12/31/2010 E. Finalize agenda, logistics, and begin to prepare materials for meeting. 3/31/2011 Completed 1/31/2011 F. Conduct initial meeting with international heads of device programs meeting. 4/30/2011 Completed 2/17/2011 G. Based on results of meeting with Int'l device leaders, revise draft plan and develop plan for next steps. 6/30/2011 Completed 6/30/2011 H. Conduct inaugural planning meeting of the new regulator-led forum. 10/31/2011 Completed 10/5/2011 I. Hold the first meeting of the International Medical Device Regulators Forum. 3/31/2012 Completed 2/28/2012 J. Participate in at least two harmonization activities with one or more foreign regulatory authorities. 9/30/2012 Completed 7/31/2012 K. Issue the final Medical Device International Standards Organization (ISO) 13485 guidance. 12/31/2012 Completed 3/19/2012 http://www.fda.gov/AboutFDA/Transparency/track/ucm203038.htm FDA-TRACK CDRH Dashboard http://www.imdrf.org/ International Medical Device Regulators Forum ਍††਍਍਍਍਍਍਍