iReview aims to serve as a workflow management tool and automate the end-to-end 510(k) review process. This new system ensures that work is not duplicated in multiple systems, technical risk is reduced, future changes to the 510(k) process can be incorporated easily without impacting other applications, and reviewers, supervisors, and consultants can use one system as a single repository for all 510(k) review status and work products.iReview goals include:<ul><li>Development of an electronic tool for reviewers to enable creation of 510(k) review memos and administrative file</li><li>Improve review consistency with structured review templates linked to guidance, standards and regulations</li><li>Ability to store review information as structured data (in CDRH's Ad Hoc Reporting System (CARS)) to support future decisions and guidance development</li><li>Ability to standardize new reviewer training</li></ul>ODE successfully completed an assessment of APPIAN for iReview; however, a final decision was made upon testing to not fully implement the tool. The primary reason for not implementing this tool was due to the inability of APPIAN software to support more complex editing requirements. While this aspect of APPIAN was known at the beginning of the project , it was believed to be an acceptable limitation of the project at the time. During the user acceptance testing, this limitation became a show stopper for iReview. Therefore, the project was completed and terminated after user acceptance testing. CDRH will be moving forward to determine the optimal approach for a consistent, flexible, intuitive and "user friendly" approach to structured data collection. This process should lead us to a solution that will be used for structured data collection across the total project life cycle instead of just premarket.A. Create a preliminary scope document4/9/2009Completed4/9/2009B. Develop statement of work6/9/2009Completed6/9/2009C. Develop project plan7/9/2009Completed7/1/2009D. Identify requirements11/1/2009Completed11/1/2009E. Identify specifications for interacting with other data systems1/1/2010Completed12/4/2009F. Complete a demo for testing and feedback2/15/2010Completed2/15/2010G. Begin user acceptance testing (UAT) of demo5/1/2010Completed5/1/2010H. Finalize UAT and identify next steps9/30/2010Completed7/27/2010http://www.fda.gov/AboutFDA/Transparency/track/ucm203038.htmFDA-TRACK CDRH Dashboard਍††਍਍਍਍਍਍਍