Devices

Five Areas to Address in Cybersecurity: Webinar

An FDA 1/12 webinar on the agency’s final guidance on postmarket management of cybersecurity in medical devices says that addressing this issue means implementing a proactive comprehensive risk management program that incorporates several tenets: applying the NIST (National Institute of Standards and Technology) framework to strengthen critical infrastructure cyber security; establishing and communicating processes for vulnerability intake and handling; adopting a coordinated disclosure policy and practice; deploying mitigations that address security risk early and prior to exploitation; and engaging in collaborative information sharing for cyber vulnerabilities and threats.

Key principles, according to CDRH associate director for science and strategic partnerships Suzanne Schwartz, are using a risk-based framework to assure that public health risks are addressed in a continual and timely fashion, manufacturer responsibility as shown in existing quality system regulations and FDA’s post-market authority, fostering a collaborative and coordinated approach to information sharing and risk assessment, and maintaining close alignment with the executive orders and the guidance’s framework.

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