CDRH receives approximately 4,000 510(k) applications per year. The review of a 510(k) is directly affected by the quality of the application. Poor submission quality requires additional FDA resources and leads to longer times before a 510(k) device gets to market. 510(k) submission quality of paper only copies is difficult to measure directly. This project uses a multi-pronged approach to evaluate various surrogates of submission quality, including analysis of additional information letters, a reviewer survey, and evaluation of the e-Copy initiative. ON TRACK ON TRACK A. Collect input from Office of Device Evaluation (ODE), OIVD (Office of In Vitro Diagnostics Evaluation and Safety (OIVD), and Center for Biologics Evaluation and Research (CBER) review staff to assess premarket submission quality using a web-based survey tool12/31/2010Completed12/1/2010B. Complete analysis of survey results1/31/2011Completed2/10/2011C. Complete analysis of a representative sample of 510(k) first action requests from Additional Information (AI) Letters & emails to determine the type & rate of deficiencies identified during the first review cycle1/31/2011Completed2/28/2011D. Develop a study plan to determine the usage of the e-Copy initiative for 510(k) applications3/11/2011Completed3/11/2011E. Begin sending usable CDs to the Reviewers/Math Statisticians to expedite data analysis of clinical data3/14/2011Completed3/14/2011F. Begin tracking incoming e-Copies of 510(k)s over a three month period by the Document Control Center (DCC). DCC will record successes and problems of e-Copy 510(k)s.6/30/2011Completed6/30/2011G. Prepare recommendation report based on findings of A through F7/31/2011<i>(9/30/2011)</i>Completed10/3/2011H. Corrective and Preventive Action (CAPA) system will go "live"10/1/2011Completed10/1/2011I. Begin the 510(k) Refuse to Accept (RTA) pilot study11/14/2011Completed11/14/2011J. Complete pilot and receive feedback from reviewers12/31/2011Completed12/23/2011K. Complete pilot analysis2/29/2012Completed1/31/2012L. Complete draft checklist and policy6/30/2012Completed6/30/2012M. Complete final RTA policy10/1/2012Completed12/31/2012N. Implement the 510(k) Refuse to Accept policy10/1/2012Completed1/1/2013O. Develop DocMan and complete initial testing 12/31/2012Completed12/31/2012P. Complete DocMan User Acceptance Testing1/31/2013Completed1/31/2013Q. Develop SMART Template and complete initial testing4/30/2013On TrackR. Complete SMART Template User Acceptance Testing6/30/2013Not Yet StartedS. Complete SMART Template Pilot (1-2 Divisions)8/30/2013Not Yet StartedT. Roll-out SMART Template to ODE10/31/2013Not Yet StartedRevised milestones are indicated in italics and parentheses beneath the original milestone date.http://www.fda.gov/AboutFDA/Transparency/track/ucm203038.htmFDA-TRACK CDRH Dashboard਍††਍਍਍਍਍਍਍