FDA gets granular with draft medical device premarket approval update

The U.S. Food & Drug Administration issued select updates to premarket cybersecurity guidance including who is required to comply, the types of devices that fall under certain agency requirements and recommendations on how to document related compliance in premarket submissions.

WHY IT MATTERS

FDA said in theFederal Register Wednesday that the proposed update to its final “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” "considers the 'ability to connect to the Internet' to include devices …

administration agency amp compliance cybersecurity device devices document draft drug fda food guidance medical medical device premarket recommendations register requirements select types under update updates