Devices

FDA Artificial Intelligence Action Plan Outlined

Two SheppardMullin attorneys say the quick takeaway from the 1/12 publication of an FDA action plan for artificial intelligence and machine learning (AI/ML) software is that the agency will publish a guidance on change control plans, a key concept from its 4/2020 discussion paper on AI/ML software devices. In an online FDA Law Update Blog post, the attorneys write that while the action plan proposes a roadmap for advancing a regulatory framework, an operational framework appears to be further down the road.

The post lists the action plan section highlights as:

FDA will hold a public workshop on algorithm transparency;
evaluating algorithm bias;
FDA will publish a draft guidance on change control plans this year;
pilot program for real-world performance monitoring; and
building consensus for good machine learning practice.

“To developers of AI/ML, the action plan may appear modest in its objectives for 2021,” the attorneys conclude. “For example, the only specific commitment for 2021 is to publish a draft guidance on predetermined change control plans, which is only one aspect of the agency’s multi-pronged approach laid out in its discussion paper. Developers, however, can view this as a continued opportunity to engage FDA and influence the agency’s thinking on key concepts that will eventually be incorporated into a comprehensive framework.”

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