FDA's Newest Medical Device Security Guidance

By Matthew M. Lowe, MasterControl

As medical devices have grown increasingly complex, so have the regulations surrounding them. This is understandable when you consider the risks posed with software and connected devices. While the U.S. Food and Drug Administration (FDA) has released guidance in the past about security in medical devices, the pace of technology warrants more frequent guidance documents. The latest FDA cybersecurity guidance to be released is still in the draft stage, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.”

We take a closer look into how the industry will respond to the release of the guidance and how manufacturers can improve their medical device cybersecurity risk management and ensure safe devices for patients.