Devices

4 FDA/ECRI Material Safety Summaries Out

FDA, which partnered with ECRI, an independent nonprofit organization, to perform a comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation, has published the first four safety summaries. The documents cover magnesium, polypropylene, polyurethane, and siloxanes.

The review for each material focused on five key questions about local and systemic response to materials commonly used in medical devices:

the typical or expected local host response to the material;
whether the material elicits a persistent or exaggerated response that may lead to systemic signs or symptoms beyond known toxicity problems;
patient-related factors that may predict, increase, or decrease the likelihood and/or severity of an exaggerated, sustained immunological/systemic response;
material-related factors that may predict, increase, or decrease the likelihood and/or severity of an exaggerated, sustained immunological/systemic response; and
critical information gaps that exist and research that is needed to better understand the issue.

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