About FDA

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.