Training -- enhance training for industry and FDA staff on quality systems, conduct of post approval studies, device recall processes, and reporting of postmarket adverse events.

Recalls -- increase industry's understanding of FDA's expectations for when a device should be recalled for a malfunction or adverse events, thresholds for when actions should be taken, and how the public should be informed.


Good Manufacturing Practices -- greater collaboration between FDA and the industry on how to achieve compliance with regulations regarding the manufacture of medical devices.

Postmarket Safety Initiative -- provide for industry input into implementation of FDA's postmarket safety initiatives.

Technology -- greater use of automated information systems to obtain and use data, including electronic submission of marketing applications.

FDA activities with industry and other stakeholders -- working groups on recalls, annual reports, condition of approval studies, and unique device identifiers. Future workshops with stakeholders on communications associated with recalls, risk management, and human factors.

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