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FDA seeks to address industry concerns about device-approval process
Modern Healthcare

Officials at the Food and Drug Administration’s Center for Devices and Radiological Health attempted to reassure medical devicemakers and other stakeholders that the agency’s efforts to overhaul the medical-device approval process will result in an improved system.

“By increasing the predictability and reliability of the review process, we can ensure patient safety and foster innovation,” CDRH Director Jeffrey Shuren said during a question-and-answer webcast on Tuesday afternoon.