Devices

Opioid Treatment Devices Study Guidance

FDA has published a guidance, Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder, with recommendations for the design of pivotal studies for devices intended to treat opioid use disorder (OUD) and used to support marketing submissions. The document says the recommendations apply to the design and development of clinical studies to provide a reasonable assurance of safety and effectiveness for a device intended to treat OUD.

“The principles discussed in this guidance are intended to assist sponsors and investigators designing studies that can provide a reasonable assurance of safety and effectiveness for a device intended to treat OUD,” the guidance says. “This guidance recommends well-controlled studies for pivotal OUD device studies, but recommendations within this guidance may be applicable to other types of studies intended to generate valid scientific evidence that may be used in providing a reasonable assurance of safety and effectiveness.”

The document says that early feasibility studies and other preliminary studies are outside its scope. Products that are outside the guidance scope are diagnostic tests for the detection of opioid use, devices intended to diagnose or to help determine the risk of developing OUD, devices intended to treat pain, and combination products.

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