Devices

Advisors Asked About Generative AI Regulation

The FDA Digital Health Advisory Committee will consider 11/20-21 FDA questions about the regulation and oversight of generative artificial intelligence (GenAI)-enabled medical devices. A briefing document distributed in advance of the committee meeting says the “novel capabilities of GenAI may offer unique benefits to patients and public health, but the use and adoption of GenAI also come with specific risks and complexities that challenge FDA’s approach to the regulation of devices.”

The document says the agency particularly faces challenges associated with applying a risk-based approach to classification and determining regulatory requirements for GenAI-enabled devices. Further, it says, for those GenAI-enabled devices that require FDA regulatory oversight, the agency faces challenges associated with determining the types of valid scientific evidence for its evaluation of the safety and effectiveness of the devices across the total product lifecycle.

The document poses questions for the committee members to discuss across premarket performance evaluation, risk management, and postmarket performance monitoring.

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