Devices

Sen. Grassley Seeks FDA Response on Cybersecurity Report

Sen. Judiciary Committee chairman Chuck Grassley (R-IA) has stepped up pressure on FDA after a recent HHS Inspector General (OIG) report said FDA should take steps to have its policies and procedures better address medical device postmarket cybersecurity risks. OIG found that FDA’s policies and procedures were insufficient for handling such events; the agency had not adequately tested its ability to respond to emergencies resulting from them and in two of 19 district offices, it had not established written standard operating procedures to address recalls of medical devices vulnerable to cyber threats.

In an 11/9 letter to commissioner Scott Gottlieb, Grassley asked for a written summary describing how the agency implemented fixes sufficient to close the OIG recommendations. Gottlieb was also asked if FDA has assessed whether foreign governments or other entities are threats to post market medical device cybersecurity. And Grassley asked for explanations on how the agency uses MDR data and whether it is being used to improve cybersecurity for medical devices.

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