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U.S. Department of Health and Human Services

About FDA

International Medical Device Regulators Forum

Description: This project proposes the development of a new, more efficient, effective, and focused collaborative effort to share information, experiences and develop strategies that improve medical device safety amongst regulatory systems tasked with responsibilities unique to global medical device regulators. This plan seeks to establish mechanisms to facilitate regulator-to-regulator organization and governance structure to facilitate exchange of information, sharing of best practices, provide opportunities to identify commonalities and develop approaches to regulatory barriers that, in the past, prohibited the implementation of global strategies.

Accomplishment: Final guidance on the Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot program was issued on March 19, 2012. CDRH began the pilot program on June 5, 2012.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Draft a plan for establishing a device regulators forum.

9/30/2010

Completed 9/30/2010

B. Propose and discuss the draft plan with heads of agencies from GHTF founding countries.

10/31/2010

Completed 10/31/2010

C. Propose and discuss the draft plan with regulators on the GHTF's Steering Committee.

11/30/2010

Completed 11/30/2010

D. Begin to organize the international heads of device programs meeting, to be held in the U.S.

12/31/2010

Completed 12/31/2010

E. Finalize agenda, logistics, and begin to prepare materials for meeting.

3/31/2011

Completed 1/31/2011

F. Conduct initial meeting with international heads of device programs meeting.

4/30/2011

Completed 2/17/2011

G. Based on results of meeting with Int'l device leaders, revise draft plan and develop plan for next steps.

6/30/2011

Completed 6/30/2011

H. Conduct inaugural planning meeting of the new regulator-led forum.

10/31/2011

Completed 10/5/2011

I. Hold the first meeting of the International Medical Device Regulators Forum.

3/31/2012

Completed 2/28/2012

J. Participate in at least two harmonization activities with one or more foreign regulatory authorities.

9/30/2012

Completed 7/31/2012

K. Issue the final Medical Device International Standards Organization (ISO) 13485 guidance.

12/31/2012

Completed 3/19/2012

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.