Devices

5 Key Points in New FDA Weight Loss Device Guidance

Manufacturers developing weight-loss devices should carefully review FDA’s 3/2026 final guidance closely, particularly the effectiveness thresholds, adverse event grading system, and evaluation matrices that will shape pivotal study design and premarket strategy. That’s the recommendation of Hogan Lovells attorneys Kristin Duggan and Megana Sarkaran, writing in an online post. They highlight these five key points from the guidance:

effectiveness thresholds are unchanged from the 9/2023 draft guidance but are significantly different from the 2012 paradigm;
four indication categories drive study design and duration;
evaluation matrices are the central benefit-risk decision aid;
the final guidance consolidates clinical and non-clinical recommendations into one document; and
several refinements from the draft to the final document should be noted.

“For device manufacturers,” the lawyers write, “the final guidance provides a clear and consolidated regulatory roadmap for both non-clinical and clinical testing for weight loss devices after more than a decade of evolving expectations. The benefit-risk framework — from the indication-specific effectiveness thresholds to the evaluation matrices — is now the reference for pivotal study design.

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