Medical Device Legal News with Sam Bernstein: Episode 11
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...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The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics,...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The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an...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The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more
FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...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On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more
On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more
On December 2 – 3 2024, the European Data Protection Board (EDPB) met for its 99th plenary session. It subsequently issued several documents, one of which calls for the need for greater alignment between the GDPR and EU...more
On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more
Welcome to the April-May edition of Akin Intelligence. This edition is a double header, covering both months as we prepare for the launch of our new AI Hub—a one-stop resource for AI coverage that will launch soon. Starting...more
European Data Protection Board Publishes Strategy for 2024-27 - The European Data Protection Board (“EDPB” - the EU body tasked with promoting consistency and cooperation in enforcement of the GDPR) has outlined its...more
On October 30, 2023, the Biden administration issued its long-awaited artificial intelligence (AI) executive order (EO), which issues directives to over 20 federal agencies, with the deadline for implementation spanning...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
Seyfarth Synopsis: Following President Biden’s comprehensive Executive Order on AI, the White House announced the formation of the “US AI Safety Institute” within the Commerce Department’s technology arm, the NIST. The...more
The California Privacy Protection Agency (CPPA) recently published two new sets of draft regulations addressing a range of cutting-edge data protection issues. Although the CPPA has not officially started the formal...more
The California Privacy Protection Agency (CPPA) recently published two new sets of draft regulations addressing a range of cutting-edge data protection issues. Although the Agency has not officially started the formal...more
FDA has cleared or approved hundreds of products that work with artificial intelligence (“AI”) and acknowledges that the agency and industry need help navigating how FDA-regulated products engage with AI. In response to the...more
The global AI market was valued at $95.60 billion in 2021 and is predicted to reach $1.85 trillion by 2030, registering a compound annual growth rate of 32.9%. Alongside this growth and the proliferation of AI use cases...more
On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The Final Guidance replaces the...more
The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more