Client Alert: FDA Releases Final Guidance Related to Connected Medical Devices

With the overwhelming growth of medical devices connected to the “internet of things,” the FDA has scrutinized the accompanying cybersecurity risks and design issues closely and has issued a variety of guidance documents in recent years.  Most recently, on September 6, 2017, the FDA released its final guidance on Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices.  Although the guidance is not binding, it provides medical device manufacturers direction and recommendations with respect to design considerations when developing interoperable medical devices, and recommendations regarding information to include in premarket submissions and device labeling.