On December 28, 2016, the U.S. Food and Drug Administration (FDA) released final guidance on the management of cybersecurity vulnerabilities for marketed and distributed medical devices. The guidance establishes a risk-based approach for the reporting of medical device cybersecurity vulnerabilities to the FDA.… Continue reading
Our sister blog, The Health Law Pulse, has just blogged on the first reported instance of anti-malware causing of a medical device failure. Medical device manufacturers may wish to keep this type of interruption in mind when considering the U.S. Food & Drug Administration’s past guidance regarding the need to balance cybersecurity safeguards and the usability of the medical … Continue reading