Devices

Draft Guide on Peripheral Vascular Atherectomy Devices

FDA has made available a draft guidance entitled “Select Updates for Peripheral Vascular Atherectomy Devices -Premarket Notification [510(k)] Submissions.” The document discusses software in atherectomy devices which may include a variety of functions ranging from ensuring that malfunctions that could be hazardous do not occur (e.g., cause injury, erroneous diagnosis, or delay in delivery) to directly controlling device cutting/lasing output. It says that adequate software performance testing provides assurance that the device is safe for the user, operator, and the patient. The guidance recommends that sponsors refer to the FDA’s software guidance, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” to determine software documentation that should be provided in submissions. Additionally, the document addresses risks associated with the presence of bacterial endotoxins, and atherectomy devices should meet pyrogen limit specifications by following recommendations outlined in the agency’s guidance, “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.”

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