Devices

Court Says FDA Can’t Ban Electrical Stimulation for One Purpose

The U.S. Court of Appeals for the District of Columbia has vacated an FDA rule that determined that electrical stimulation devices used to treat aggressive or self-injurious behavior present an unreasonable and substantial risk of illness or injury, but only when used to treat aggressive or self-injurious behaviors. The agency rule was challenged in court by the Judge Rotenberg Educational Center and the parents and guardians of its patients. The center is the only treatment venue in the U.S. to use the devices for this indication.

The court held that federal law says that FDA is not to interfere with the practice of medicine. “That means that FDA may not enact the regulation at issue before us,” the court said in a 2-1 opinion. “Because we conclude that FDA lacks the statutory authority to ban a medical device for a particular use, we do not address petitioners’ other arguments, including whether the ban was arbitrary and capricious or whether substantial evidence supported FDA’s factual determinations.”

A dissenting opinion said that while the petitioners presented a permissible legal theory opposing the agency’s ability to ban a device for a specific use, FDA also presented a legally permissible interpretation of the law and should be granted deference.

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