Medical devices offer significant health benefits, but must be balanced against certain risks. A strong Medical Device Postmarket Surveillance System (MDS) can provide more robust and timely benefit-risk profiles for devices so that providers and patients can make better informed health care decisions.

In 2013, after receiving public input on the 2012 strategy, the FDA’s Center for Devices and Radiological Health published an update that described the five major steps the FDA would take to create the MDS.

Last week, the FDA released its report “Strengthening Patient Care: Building an Effective National Medical Device Surveillance System,” which outlines recommended steps toward achieving the MDS and strategies for implementation. The report provides a pathway to realizing a national system that harnesses novel data sources, modern analytical techniques, and the participation of all stakeholders to optimize patient care.

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