Devices

Attend to Cybersecurity Guidelines: Attorney

Attorney Paulette Thomas (BaketHostetler) says it is imperative that hospitals and other vendors take seriously the FDA Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, which she describes as the latest step in the agency’s ongoing effort to enhance medical device security. Writing in an online HIT Consultant post, Thomas says FDA’s primary focus is on patient safety related to medical device incidents, and cautions that the guidelines could come into play if and when potential litigation over a device security incident arises.

“The playbook provides guidance to healthcare organizations, recommending a layering approach to medical device incident preparedness and response by utilizing the healthcare organization’s current emergency preparedness plans,” she writes. “If a solid emergency preparedness plan is already in place, complying with these new guidelines may not cause too much heartache. But now is always a good time to review your organization’s emergency preparedness plan to ensure that it is compliant with all regulations and available guidance.”

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