The U.S. Food and Drug Administration (“FDA”) has announced plans to create a centralized digital health unit within the Center for Devices and Radiological Health (“CDRH”), further supporting CDRH’s 2016-2017 vision to establish a more robust national evaluation system for
Center for Devices and Radiological Health
FDA finalizes guidance on medical device safety
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The Food and Drug Administration (“FDA”) released its final guidance on medical device safety on December 14, 2016, titled “Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals).” The final guidance comes almost a year after FDA issued a…