The US Food and Drug Administration is considering several new measures to address medical device safety and cybersecurity, including a new public-private coordinating board to evaluate high-risk, high-impact connected devices. The cybersecurity and related measures make up the agency’s new Medical Device Safety Action Plan, developed to focus also on issues including streamlined post-market processes; foster innovation to boost device safety; and merge the Center for Devices and Radiological Health’s (CDRH) premarket and post-market branches to advance a “Total Product Lifecycle” or TPLC approach to device evaluation and oversight. Cybersecurity
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