Devices

Legislation for More AI/ML Flexibility Needed: Shuren

CDRH director Jeffrey Shuren says he would like to see legislative changes that would give the Center greater regulatory flexibility in dealing with artificial intelligence/machine learning (AI/ML)-driven medical devices. Speaking to a 3/22 Duke Margolis Center for Health Policy Webinar on regulation, development, and real-world performance evaluation of AI/ML, Shuren noted that many of the regulatory pathways available to CDRH were developed decades ago to meet the technology that was available then. He said that it will be important in the future to have greater regulatory flexibility and agility so the Center can create pathways that are better for innovative technology.

In his presentation, Shuren said the Center’s AI/ML action plan approved in 2021 was an “invitation to collaborate [issued] to a broad range of stakeholders.” He noted that CDRH is active in several collaborative communities in the digital health space, having committed to participating in at least 10 such communities. “Such an approach is going to become business as usual for us,” he said.

Shuren also stressed the importance of transparency as a factor that leads to informed decisions by patients and healthcare professionals, safe and effective device use, health equity, monitoring device performance, and trust.

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