Drugs

Bill Introduced for Streamlined Device Accessory Classification

Reps. Ann Kuster (D-NH) and Mimi Walters (R-CA) have introduced HR 2144 that would require FDA to implement an efficient, streamlined process for classifying medical device accessories. In announcing support for the measure, the Advanced Medical Technology Association (AdvaMed) said it would “establish a new procedural mechanism for accessory classification, based on the sponsor’s recommendation supported by relevant data and information. The bill also would allow the agency to efficiently re-classify accessories currently on the market that are subject to an inappropriate risk classification.”

AdvaMed noted that the recently passed 21^st Century Cures Act included a provision directing FDA to classify a device accessory independent of its parent device, “which corrected a long-standing deficiency in the agency’s review process that led to many accessories being unfairly subject to higher-risk classification than was necessary for their safe and effective use. However, FDA does not have a good mechanism for implementing this provision or for addressing the hundreds of accessories currently on the market which may be inappropriately classified... A tailored review approach for device accessories would improve FDA’s efficiency and save the agency resources while ensuring patients continue to benefit from safe and effective medical technologies.”

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