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Originally Published MD&DI October 2007

NEWS TRENDS

FDA and DoD to Share Device Data

Maria Fontanazza

FDA and the Department of Defense (DoD) are partnering to share data related to how medical devices, biologics, and drugs are reviewed and used. The agreement is part of FDA’s Sentinel Network, an integrated, electronic postmarket safety network that aims to provide product safety information directly to clinicians.

Part of the purpose of the memorandum of understanding (MOU) is to build the infrastructure and processes that meet requirements for assessing the safety, efficacy, and use of devices and drugs. It also seeks to promote better use of tools for risk identification, validation, and analysis of products. Sharing product information could help FDA identify potential concerns and other trends.

Although patient data such as prescriptions and lab results will be shared between the agencies, FDA and DoD have agreed not to share information under the MOU until proper safeguards are put into place. Each agency will appoint liaisons, including one from CDRH, to handle activities under the partnership.

The MOU was signed in July by FDA commissioner Andrew von Eschenbach and W. Ward Casscells, MD, assistant secretary of defense for health affairs at the DoD. The agencies are planning to meet later in the year to discuss details of the agreement.








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