Devices

HHS Inspector General Assessing Device Surveillance

HHS’s Office of Inspector General (OIG)says it is assessing FDA’s medical device postmarket surveillance activities. “As the information that the FDA receives about medical device safety and effectiveness is increasingly gathered in the postmarket setting, it is more important than ever that FDA’s postmarket safety surveillance system can effectively identify and act on safety signals,” OIG says in an work plan update.

OIG says it will complete and report on its assessment in 2020. “We will assess and describe how FDA’s established passive postmarket surveillance system identifies and tracks safety concerns, and assess FDA’s response to those concerns,” it says. “We will also describe how elements of FDA’s newer surveillance system initiatives, such as the Unique Device Identification system, are being integrated into the passive postmarket surveillance system. In addition, we will describe how FDA plans to integrate these initiatives into the National Evaluation System for health Technology, its in-development active postmarket surveillance system.”

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