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FDA and DoD collaborate on safety

Device Regulation Alert: Safety, Compliance and Reimbursement News, August 27, 2007

The FDA and the Department of Defense will partner to enhance safety review of medical devices and other FDA-regulated products by sharing data and expertise. According to an August 2 FDA press release, the U.S. Military Health System will share patient data such as prescriptions and lab results to help the FDA spot trends and potential problems involving FDA-regulated medical devices, drugs, and biologics. The FDA release says this step is part of its medical product safety initiative, the "Sentinel Network," first announced in January this year.

A Memorandum of Understanding sets forth details of the partnership but the FDA and DoD must still finalize "specific procedures and safeguards" concerning its implementation.

The Memorandum of Understanding expresses the intent of the partnership to "enhance knowledge and efficiency" by sharing information. The partnership's goals, according to the Memorandum, are to:

To view the FDA press release and a link to the Memorandum of Understanding click here.

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