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CDRH Transparency and Decision-Making

Description: To enhance our credibility, CDRH will provide up to date information to our constituents about our regulatory decisions and the rationale for those decisions.

Accomplishment: In support of the FDA Transparency Initiative, CDRH developed the CDRH Transparency website to provide additional information to help the public understand its processes and decisions. The website includes information about regulatory decisions and the rationales for those decision, descriptions of regulatory processes and data to support CDRH actions and public health activities. The website was launched on April 19, 2010 and has been very well received. CDRH continues to post new information as it becomes available and make improvements to the website based on suggestions and comments received from the public. Therefore, at this stage, the website is in a maintenance mode.

Milestone Description	Milestone Date	Milestone Status	Milestone Completion Date
A. Identify information that CDRH will make public through our transparency website	11/30/2009	Completed	11/30/2009
B. Launch Traction website (1)	12/31/2009	Completed	12/31/2009
C. Prioritize information that CDRH will make public through our transparency website	1/31/2010	Completed	1/31/2010
D. Begin to develop CDRH's transparency website	1/31/2010	Completed	1/31/2010
E. Launch CDRH's transparency website	4/30/2010	Completed	4/19/2010
F. Begin to obtain feedback from our constituents about CDRH's transparency initiative	5/31/2010	Completed	4/19/2010
G. Launch CDRH's improved Medical Device Safety website	6/30/2010	Completed	6/30/2010
H. Update CDRH's transparency website based on feedback from our constituents	8/15/2010	Completed	8/15/2010
I. Develop FY11 list of Transparency Projects	10/31/2010	Completed	10/31/2010
J. Finalize FY11 list of Transparency Projects	11/30/2010	Completed	11/30/2010
K. Complete Medical Device and Radiation-emitting product information for FDA Transparency and post to FDA Basics for Industry website	12/31/2010	Completed	1/5/2011

Foot Notes

(1) Traction is collaborative software licensed by FDA to help employees collaborate and communicate. With Traction, employees can share information, collaborate on issues, manage documents, and stay informed about what's going on in their Office, Center, and throughout FDA.

Key Projects Legend

Milestone Status	Definition
Not Yet Started	Work for specific milestone has not yet been started.
Completed	Milestone and/or overall project is completed.
On Track	Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On Hold	Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
Delayed	Milestone - 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.