Tag archives: Center for Devices and Radiological Health

FDA announces plans to create a centralized digital health unit

By Benjamin Wallfisch (US) on May 9, 2017 Posted in FDA & Food Safety

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 medical devices. FDA will form the new digital health unit within CDRH’s Office of the … Continue reading

FDA finalizes guidance on medical device safety

By Carol Poindexter (US) on December 19, 2016 Posted in FDA & Food Safety

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 The final guidance comes almost a year after FDA issued a similar draft guidance on the topic. As with the draft guidance, industry remains concerned about … Continue reading