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U.S. Department of Health and Human Services

About FDA

Medical Device and Radiation-Emitting Product Recall Process Improvement Project

Description: The overall objective of this project is to enhance public health by improving the efficiency and clarity of the medical device and radiation-emitting product recall process. More specifically, this project aims to:

  • Improve recall classification timeliness to ensure FDA classifies recalls in a timely manner. Recall classifications (Class I, II, or III) indicate the relative degree of public health risk due to device malfunction, and are critical for determining the appropriate communication, corrective action plan and termination of the recall; and
  • Improve recall clarity as it relates to stakeholder responsibilities and communication with healthcare professionals and the public throughout the process.

    Accomplishment: This key project is complete. CDRH improved the medical device recall process which decreased processing times and improved communications by streamlining the process, analyzing data and clarifying our recall-related duties. 19 improvement strategies were identified and implemented in 2012 resulting in the elimination of backlogs and delays. A CDRH screening process improved timeliness. Outreach to industry was improved through the development and public posting of the recall notification letter template, the recall press release template, and industry training modules. The recall process improvements implemented as a part of this project resulted in an 89% increase in the meeting of recall classification timeframes since internal tracking began in FY 2010.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Assess existing recall process and determine the scope of the recall improvement project

11/30/2010

Completed 11/15/2010

B. Create and staff teams to address identified areas for improvement

12/30/2010

Completed 12/8/2010

C. Prioritize improvement project components and develop preliminary action plans with timelines, milestones, and deliverables

3/1/2011

Completed 2/1/2011

D. Select 2 strategies to improve recall classification or clarity

3/31/2011

Completed 3/31/2011

E. Complete training and begin implementation of 2 strategies

10/31/2011

Completed 7/29/2011

F. Select a third strategy to improve recall classification or clarity

11/30/2011

Completed 8/31/2011

G. Assess FY2011 recall timeliness and effect of new strategy implementation

12/31/2011

Completed 12/31/2011

H. Initiate work on 3 to 5 additional strategies to improve recall classification or clarity

12/31/2011

Completed 12/31/2011

I. Implement one strategy

3/31/2012

Completed 3/31/2012

J. Implement 1 additional strategy

6/30/2012

Completed 6/30/2012

K. Assess mid year FY2012 recall timeliness and effect of new strategy implementation

7/31/2012

Completed 7/31/2012

L. Select two additional strategies to implement

7/31/2012

Completed 7/31/2012

M. Implement selected strategies

9/30/2012

Completed 12/3/2012

N. Assess recall improvement needs

12/30/2012

Completed 12/17/2012

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.