Medical Device Legal News with Sam Bernstein: Episode 11
Over the last few years, the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more
The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more
On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more
Welcome to this week's issue of AI: The Washington Report, a joint undertaking of Mintz and its government affairs affiliate, ML Strategies. The accelerating advances in artificial intelligence (“AI”) and the practical,...more
Medical device cybersecurity continues to create buzz, as the FBI issues a Private Industry Notification to health care providers outlining cybersecurity risks for medical devices. This follows FDA’s released Draft Guidance...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more
On April 8, 2022, FDA issued new, long-awaited draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (Draft Cybersecurity Guidance). 1 This draft guidance...more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 Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more
On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on designing...more
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks. The...more
On January 22, 2016, the US Food and Drug Administration ("FDA") issued draft guidance outlining important steps medical device manufacturers should take to address cybersecurity risks in order to improve patient safety and...more
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance titled “Postmarket Management of Cybersecurity in Medical Devices,” setting forth proposed recommendations for the medical device industry as...more
The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity. Recognizing the growing importance of cybersecurity for medical devices and the potential public...more
It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called...more
On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more
On January 15, 2016, the U.S. Food and Drug Administration (FDA) announced in a Press Release that it would issue draft guidance on January 22 outlining “steps medical device manufacturers should take to continually address...more