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.
Briefing Status: ON TRACK
Prior Briefing Status: ON TRACK
| Milestone Description | Milestone Date | Milestone Status | Milestone 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 |
On Track |
Footnotes
- (1) Milestone N has been retired and replaced by Milestone O as the project took a new direction.
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.
