"Diabetes Patients Flood FDA with Comments on Cybersecurity for Medical Devices"

More than a thousand comments were submitted to the Food and Drug Administration (FDA) in response to a draft cybersecurity guidance intended for staff to use when reviewing applications from medical device manufacturers seeking approval to market their products. The majority of these comments came from diabetes patients and their families. One of the comments FDA posted to the docket on the guidance states, "Please do not let medical device makers claim cybersecurity as a pretense to block me from using my own devices." The FDA will now start the process of developing cybersecurity recommendations for its pre-market submissions after a 90-day public comment period. Congress is pressuring the FDA to improve the cybersecurity of medical devices through its pre-market approval process. According to some scholars, the agency's next steps could serve as a model for a sector-specific approach to regulating and enforcing reasonable measures for securing an increasingly connected world from malicious actors. This article continues to discuss diabetes patients' comments to the FDA pertaining to the cybersecurity of medical devices. 

NextGov reports "Diabetes Patients Flood FDA with Comments on Cybersecurity for Medical Devices"