Devices

FDA Again Seeks Ban on Shock Devices

FDA is again proposing to ban electrical stimulation devices intended to reduce or stop self-injurious or aggressive behavior. The agency has determined that this rare regulatory move is necessary because the devices present an unreasonable and substantial risk of illness or injury.

FDA issued a final rule in 2020 banning the devices, but this was vacated by the U.S. Court of Appeals for the District of Columbia Circuit on 7/6/2021. In its ruling, the court found that FDA did not have authority to ban some, but not all, of its intended uses. Subsequently, Congress amended the FD&C Act to expressly state that FDA’s authority to ban a device includes the authority to ban some of a device’s intended uses. The new proposed rule, if finalized, would reestablish the ban now that it is clear that the agency has the authority to do so.

The devices are intended to deliver electrical shocks through electrodes attached to an individual’s skin to attempt to reduce or stop harmful behaviors, FDA says. “Notably, some people who exhibit self-injurious or aggressive behavior have intellectual or developmental disabilities that make it difficult for them to communicate or make their own treatment decisions,” it explains. “These devices present a number of psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage.”

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