Devices

Arthroscopy Pump Tubing 510(k) Guidance

FDA has issued a guidance, Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use—Premarket Notification (510(k)) Submissions, with submission recommendations for these devices designed to deliver irrigation fluid to a surgical site such as the knee, shoulder, hip, elbow, ankle, and wrist joints during arthroscopic procedures. The document outlines the device design considerations, risk mitigation strategies, and testing recommendations for arthroscopy pump tubing sets intended for multiple patient use. It also clarifies the terminology used to describe arthroscopy pump tubing sets intended for multiple patient use.

FDA says the document’s scope is limited to specified Class 2 arthroscopy pump tubing sets.

“While FDA believes the recommendations listed below serve as rigorous risk mitigation strategies for reducing the risk of cross-contamination between patients,” the guidance says, “it should be noted that the only way to eliminate the risk of cross-contamination from multiple patient use is to utilize single patient use arthroscopy pump tubing sets.”

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