Devices

Digital Health Advisory Committee AI Meeting Materials

Well in advance of the 11/20-21 meeting of the FDA Digital Health Advisory Committee to discuss “Total Product Lifecycle Considerations for Generative AI-Enabled Devices,” FDA has published a meeting executive summary and questions the panel is being asked to discuss. The summary says that the novel capabilities of artificial intelligence (AI) “may offer unique benefits to patients and public health, but the use and adoption of generative AI (genAI) also come with specific risks and complexities that challenge FDA’s approach to the regulation of devices.”

In particular, it says, FDA faces challenges associated with applying a risk-based approach to classification and determining regulatory requirements for GenAI-enabled devices and for those GenAI-enabled devices that require FDA regulatory oversight. “FDA faces challenges associated with determining the types of valid scientific evidence for FDA’s evaluation of the safety and effectiveness of GenAI-enabled devices across the total product lifecycle,” it says.

The executive summary includes an Introduction, A Lifecycle Management Approach to AI, FDA’s Regulatory Oversight of GenAI-enabled Devices, Challenges for GenAI-enabled Devices and a Total Product Lifecycle Regulatory Approach, In Summary, Panel Questions, Appendix, and Glossary.

The document lists sub-questions under each of these broad question areas:

premarket performance evaluation;
risk management; and
post-market 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

Read more

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