The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren outlined the agency’s ambitious 2017 goals at an important session that was part of the conference of the Regulatory Affairs Professionals Society that was held Sept. 18, 2016, in San Jose, California. Shuren’s presentation was one of several sessions of particular interest to life sciences shops.

During his presentation, Shuren talked about the agency’s new strategy to use more real-world evidence to track the safety of medical devices. According to its Strategic Priorities Report for 2016–2017, the agency is developing a nationwide medical device evaluation system to more quickly identify safety signals, particularly through electronic health records, registries, and medical billing claims in which unique device identifiers are being used.

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