The overall objective of this project is to enhance public health by improving the efficiency and clarity of the medical device and radiation-emitting product recall process. More specifically, this project aims to: <ul><li>Improve recall classification timeliness to ensure FDA classifies recalls in a timely manner. Recall classifications (Class I, II, or III) indicate the relative degree of public health risk due to device malfunction, and are critical for determining the appropriate communication, corrective action plan and termination of the recall; and</li><li>Improve recall clarity as it relates to stakeholder responsibilities and communication with healthcare professionals and the public throughout the process. This key project is complete. CDRH improved the medical device recall process which decreased processing times and improved communications by streamlining the process, analyzing data and clarifying our recall-related duties. 19 improvement strategies were identified and implemented in 2012 resulting in the elimination of backlogs and delays. A CDRH screening process improved timeliness. Outreach to industry was improved through the development and public posting of the recall notification letter template, the recall press release template, and industry training modules. The recall process improvements implemented as a part of this project resulted in an 89% increase in the meeting of recall classification timeframes since internal tracking began in FY 2010. A. Assess existing recall process and determine the scope of the recall improvement project 11/30/2010 Completed 11/15/2010 B. Create and staff teams to address identified areas for improvement 12/30/2010 Completed 12/8/2010 C. Prioritize improvement project components and develop preliminary action plans with timelines, milestones, and deliverables 3/1/2011 Completed 2/1/2011 D. Select 2 strategies to improve recall classification or clarity 3/31/2011 Completed 3/31/2011 E. Complete training and begin implementation of 2 strategies 10/31/2011 Completed 7/29/2011 F. Select a third strategy to improve recall classification or clarity 11/30/2011 Completed 8/31/2011 G. Assess FY2011 recall timeliness and effect of new strategy implementation 12/31/2011 Completed 12/31/2011 H. Initiate work on 3 to 5 additional strategies to improve recall classification or clarity 12/31/2011 Completed 12/31/2011 I. Implement one strategy 3/31/2012 Completed 3/31/2012 J. Implement 1 additional strategy 6/30/2012 Completed 6/30/2012 K. Assess mid year FY2012 recall timeliness and effect of new strategy implementation 7/31/2012 Completed 7/31/2012 L. Select two additional strategies to implement 7/31/2012 Completed 7/31/2012 M. Implement selected strategies 9/30/2012 Completed 12/3/2012 N. Assess recall improvement needs 12/30/2012 Completed 12/17/2012 http://www.fda.gov/AboutFDA/Transparency/track/ucm203038.htm FDA-TRACK CDRH Dashboard ਍††਍਍਍਍਍਍਍