FDA Looks To Lead World In Post-Market Device Surveillance With Safety Plan, Investments

US FDA Nov. 20 announced plans for a broad series of updates to its Medical Device Safety Action Plan for the next several months, with the goal that FDA "is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.

FDA commissioner Scott Gottlieb
Commissioner Scott Gottlieb suggests more updates are coming to the device post-market surveillance system, and to the 510(k) review program.

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