Sentinel Initiative Contract to Track Device Safety

The FDA has awarded a contract to Harvard Pilgrim Healthcare as part of its Sentinel Initiative to track the safety of devices, drugs and biologics through postmarket surveillance. The contract is the FDA’s latest step to gain access to data on 25 million patients by July 1, which could help it analyze reports of acute events and other safety information to determine if additional safety measures are needed for marketed products.
Devices & Diagnostics Letter