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U.S. Department of Health and Human Services

About FDA

Medical Countermeasure Devices

Description: The goal of this project is to develop and implement the use of comprehensive test panels for the evaluation of multi-use screening, detection, and characterization assays. The project, which will be carried out in collaboration with other government agencies, will support and expedite consequence management efforts in response to intentionally released or natural events associated with high priority biological threat agents.

Briefing Status: DELAYED

Prior Briefing Status: DELAYED

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Clear a draft guidance document for Highly Multiplexed Microbiology/MCM Devices

6/30/2012

Completed 9/25/2012

2. Define, construct, and qualify validated nucleic acid panels to facilitate development of commercial and non-commercial MCM devices for the detection of biothreat agents

9/30/2012

(9/30/2013)

Completed 9/30/2013

3. Continue to implement and refine a process to help developers of influenza detection devices further evaluate reactivity of their devices for CLIA waiver purposes

9/30/2012

(9/30/2013)

(5/31/2014)

Delayed

4. Hold at least one inter-agency meeting in support of our collaborative effort to develop and maintain a high quality reference database that can be utilized to validate results of nucleic acid /sequencing based diagnostic assays

9/30/2012

Completed 9/14/2012

Footnotes

  • The dates in italics are modified milestone due dates that have been updated due to real-time delays. The milestone status reflects the current reporting quarter’s status. If a milestone is missed, the milestone will remain delayed until the milestone is completed.

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.