US Regulators Propose Expanded Medical Device Cybersecurity Approach
May 1, 2018
By Neozene

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