Devices

Still No FDA AI/ML Consistent Standards: Attorneys

Two Morrison & Foerster Life Sciences attorneys say FDA is slowly acting on its commitment to developing a regulatory framework for artificial intelligence/machine learning (AI/ML)-based software as medical devices, but still has not provided any consistent standards. In an online analysis of the agency’s steps, the attorneys say that without widely-applicable guidance, manufacturers should expect a longer application timeline and extensive discussions with FDA, essentially creating a customized plan for data and evidence generation for each AI/ML software as a medical device.

“It is unpredictable at this stage what FDA will require and ask for in these negotiations, although to some extent prior submissions and authorizations serve as a baseline for consideration,” the post concludes. “As artificial intelligence and machine learning technologies are increasing in availability and applicability, organizations and device sponsors will continue to build their own databases and define their own standards, which FDA may be strategically waiting for.”

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