Devices

CDRH Still Working on AL/MI Guidance: Attorneys

Jones Day attorneys say CDRH is considering a total product lifecycle-based framework for the oversight of artificial intelligence/machine learning (AI/ML)-enabled medical devices that would “allow for modifications to be made from real-world learning and adaptation while ensuring that the safety and effectiveness” of these devices are maintained. Writing in their firm’s Summer 2022 Digital Health Law Update, the attorneys say that while FDA has not yet published its long-awaited draft guidance on marketing submission recommendations for a change control plan for AI/ML-enabled device software functions, it published 11/2021 a draft guidance for the control of premarket submissions for device software functions.

“This guidance describes the information that FDA considers important during its evaluation of the safety and effectiveness of a device in a premarket submission,” the attorneys say, and “may help facilitate FDA’s premarket review. When finalized, it would update and replace guidance previously issued in 2005.”

The attorneys note that in the agency’s March proposed recommendations for the fifth MDUFA reauthorization, it reaffirmed its commitment to building software and digital health expertise and streamlining FDA review processes for digital health products.

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