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U.S. Department of Health and Human Services

About FDA

Medical Device Epidemiology Network (MDEpiNET)

Description: Enhance epidemiological assessment of medical device performance by establishing an extramural collaborative network with ten leading academic institutions that have experience with medical device studies. The ultimate long-term goal is to substantially contribute to the understanding of medical device performance and CDRH decision making, thereby improving public health, with a shorter term focus on building a research infrastructure by linking CDRH with leading academic organizations in the country that have experience with medical device studies.

Accomplishment: MDEpiNet has advanced from concept to operational public-private partnership over the period of this project. Significant investment has been made to fund scientific projects to develop new methodology and infrastructure for medical device epidemiology and surveillance. For example, in the field of orthopedic devices, the MDEpiNet partnership resulted in the development of the International Consortium of Orthopedic Registries (ICOR), a pioneering worldwide effort to share data and perform distributed analyses on the safety and effectiveness of medical devices used in orthopedic procedures with data collected from over 20 countries.

2013 represents a new phase of this work with the establishment of a MDEpiNet Partnership Coordinating center and reliance on MDEpiNet as a central component of the implementation of the National Medical Device Postmarket Surveillance Plan.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Establish MDEpiNet Partnership Development Team to develop a research plan

2/28/2010

Completed 2/28/2010

B. Hold kickoff workshop with academic stakeholders

4/30/2010

Completed 4/30/2010

C. Award the contract for administration of MDEpiNet

9/30/2010

Completed 9/30/2010

D. Award contracts for 3-4 pilot projects to MDEpiNet academic centers

9/30/2010

Completed 9/30/2010

E. Establish formal partnerships with MDEpiNet academic centers

12/31/2010

Completed 12/31/2011

F. Receive 1st Quarterly Report (all pilot projects)

12/31/2010

Completed 12/31/2010

G. Receive 2nd Quarterly Report (all pilot projects)

3/31/2011

Completed 3/31/2011

H. Receive 3rd Quarterly Report (all pilot projects)

6/30/2011

Completed 6/30/2011

I. Receive final report (all pilot projects)

9/30/2011

Completed 9/30/2011

J. Evaluate the success of the MDEpiNet Program

12/31/2011

Completed 12/31/2011

K. Launch a dedicated website for MDEpiNet on fda.gov domain

6/30/2012

Completed 4/3/2012

L. Hold a public workshop inviting stakeholders to discuss MDEpiNet accomplishments and future directions

6/30/2012

(9/11/2012)

Completed 9/11/2012

M. Award cooperative agreement(s) to support MCM-priority projects

9/30/2012

Completed 9/11/2012

N. Publish a partnership charter detailing operations of MDEpiNet and roles and responsibilities of all partners, including FDA (1)

N/A

Not Completed N/A

O. Issue a request for information (RFI) soliciting feedback on how to structure and run the MDEpiNet Partnership

12/31/2012

Completed 12/11/2012

P. Meeting of MDEpiNet Advisory Committee to obtain input on structure, governance and scientific plans for MDEpiNet

3/7/2013

Completed 3/7/2013

Footnotes

  • (1) Milestone N has been retired and replaced by Milestone O as the project took a new direction.

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.