Devices

FDA Expanding Real-World Evidence Use in Device Regulation

FDA says it is “redoubling efforts to utilize real-world evidence (RWE) across a wider range of medical devices to support timely access to safe and effective technologies, foster innovation, and strengthen the foundation of regulatory decision-making.” To that end, the agency has published a new set of 73 examples of marketing authorizations using RWE from FY 2020-2025, building on the foundation of a 2021 publication.

Writing in an FDA Voices online post, CDRH director Michelle Tarver and CDRH Office of Clinical Evidence and Analysis director Daniel Carlos say the 73 new examples “represent a broad spectrum of clinical and device areas throughout CDRH across the total product lifecycle while demonstrating the evolving landscape of data sources used to generate RWE. However, they do not represent an exhaustive list of all submissions that have relied on RWE, at least in part, to inform a regulatory decision. While registries have long played a central role, other data sources such as electronic health records aggregators, administrative claims and billing data, device-generated data, digital health platforms, and increasingly sophisticated data linkages are contributing to a broader and more dynamic evidence environment.”

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