FDA Policy/General

FDA’s Central Role in AI Regulation

FDA commissioner Robert Califf and two agency colleagues say that historic advances in artificial intelligence (AI) applied to biomedicine and healthcare “must be matched by continuous complementary efforts to better understand how AI performs in the settings in which it is deployed.” Writing in a JAMA Special Communication, the authors say the effort “will entail a comprehensive approach reaching far beyond FDA, spanning the consumer and healthcare ecosystems to keep pace with accelerating technical progress. If not, there is a risk that AI could disappoint similar to other general-purpose technologies deployed in healthcare settings or even create significant harm if untended models’ performance deteriorates or focuses on financial return without adequate attention to impact on clinical outcomes.”

The article says strong oversight by FDA and other agencies aims to protect the long-term success of regulated products by maintaining a high grade of public trust in the regulated space.

It looks at FDA’s history of regulating AI-enabled products and discusses these concepts pertinent to FDA regulation of AI:

AI regulation within the broader U.S. government and global context;
keeping up with the pace of change in AI;
flexible approaches across the spectrum of AI models;
the use of AI in medical product development;
preparing for the unknowns of large language models and generative AI;
the central importance of AI life cycle management;
the responsibilities of regulated industries;
maintaining robust supply chains;
finding the balance between big tech, start-ups, and academia; and
the tension between using AI to optimize financial returns vs. improving health outcomes.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome