On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more
ALERT: Recent guidance from the Food and Drug Administration (“FDA”) clarifies a procedural issue for premarket submissions related to cybersecurity of medical devices and emphasizes the importance of collaboration between...more
The U.S. Food and Drug Administration (FDA or the Agency) published guidance regarding cybersecurity requirements for certain device premarket submissions (the Guidance). The Guidance outlines the implementation of new...more
On April 8, 2022, FDA issued new, long-awaited draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (Draft Cybersecurity Guidance). 1 This draft guidance...more
The Situation: As medical devices become more connected to each other and to the internet, an increasing number of patients are exposed to cybersecurity risks. The Result: Over the last five years, the Food and Drug...more
With more and more medical devices connected to the Internet of Things (IoT), there is increasing concern over the potential vulnerabilities for cyberattacks against such devices. This vulnerability represents not only...more
The U.S. Food and Drug Administration (FDA) recently issued a dense, 24-page draft guidance, titled "Content of Premarket Submissions for Management of Cyber Security in Medical Devices" (the guidance). The guidance notes...more
On October 18, 2018, FDA issued a long-awaited draft revision to its existing guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"(premarket cybersecurity guidance). This coincided...more
In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the...more
Medical devices increasingly contain software or connect to networks that may leave the devices vulnerable to cyber-attacks. The U.S. Food and Drug Administration (“FDA”) has recognized the potential risks that these...more
The FDA recently issued a Safety Communication on cybersecurity and medical devices and draft guidance recommending that manufacturers specifically address cybersecurity in premarket submissions for medical devices....more