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U.S. Department of Health and Human Services

About FDA

iReview

Description: 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:

  • Development of an electronic tool for reviewers to enable creation of 510(k) review memos and administrative file
  • Improve review consistency with structured review templates linked to guidance, standards and regulations
  • Ability to store review information as structured data (in CDRH's Ad Hoc Reporting System (CARS)) to support future decisions and guidance development
  • Ability to standardize new reviewer training

Accomplishment: 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.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Create a preliminary scope document

4/9/2009

Completed 4/9/2009

B. Develop statement of work

6/9/2009

Completed 6/9/2009

C. Develop project plan

7/9/2009

Completed 7/1/2009

D. Identify requirements

11/1/2009

Completed 11/1/2009

E. Identify specifications for interacting with other data systems

1/1/2010

Completed 12/4/2009

F. Complete a demo for testing and feedback

2/15/2010

Completed 2/15/2010

G. Begin user acceptance testing (UAT) of demo

5/1/2010

Completed 5/1/2010

H. Finalize UAT and identify next steps

9/30/2010

Completed 7/27/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.