In Westlaw Today, Greg Levine and Beth Weinman Analyze FDA Final Guidance on Medical Device Manufacturer Cybersecurity Responsibilities

In a Westlaw Today article, Life Sciences Regulatory & Compliance (LSRC) practice group chair Greg Levine and LSRC counsel Beth Weinman examined a recent Food and Drug Administration final guidance that provides recommendations to medical device manufacturers regarding cybersecurity device design, labeling, and the documentation that the agency recommends be included in premarket submissions for devices with cybersecurity risk.

The authors note that even with FDA agency satisfaction at the time of clearance or approval, medical device manufacturers must continue to take appropriate steps to monitor for and mitigate emerging risks once a device is on the market. Documentation of such efforts will be a company's best defense as it navigates the growing minefield of cybersecurity litigation and enforcement.