Devices

Congressman Supports FDA Device Cybersecurity Efforts

Rep. Jim Langevin (D-RI), who co-chairs the Congressional Cybersecurity Caucus, is supporting FDA’s draft guidance on “Postmarket Management of Cybersecurity in Medical Devices.” In a 4/21 letter to the agency, Langevin said the guidance, when finalized, should help improve medical device cybersecurity.

“The risk-based nature of the guidance extends to the recommended cybersecurity practices medical device manufacturers should adopt,” he told FDA. “Rather than outline specific controls, which would rapidly become obsolete, the guidance suggests processes, such as monitoring cybersecurity information sources, that are tied to a holistic model of risk. Of note are the recommendations regarding vulnerability handling and disclosure, as effective vulnerability programs are essential for alerting manufacturers to security problems.”

Beyond the guidance, Langevin urged FDA to ensure that manufacturers are properly complying with the proposed mitigation methods or are properly reporting cybersecurity risks under 21 CFR part 806. “I encourage FDA to build upon its successful collaborations with industry in this space as exemplified by the cybersecurity workshops begun in 2014,” he said. “By working together with manufacturers, caregivers, patients, information technology experts, and security researchers, FDA can build a safer environment that still allows for innovations around medical device networking.”

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