Devices

CDRH Endorses Device Cybersecurity Standard

CDRH says it has recognized and supports industry’s use of a key consensus standard to support device sponsors in their cybersecurity efforts. The standard in entitled “ANSI/AAMI SW96:2023 Standard for medical device security —- Security risk management for device manufacturers.” The Center says it “aligns with existing international safety risk management standards and quality systems expectations, and provides direction to sponsors on how to consider and address cybersecurity risks in device design and development.”

The standard is intended to provide requirements and guidance when addressing design, production and post-production security risk management for devices within the risk management framework defined by ISO 14971, according to the agency. It assists manufacturers with identifying threats, vulnerabilities, and assets associated with medical devices and their components and supply chain vendors. It also helps firms determine appropriate security risk controls to reduce security risks, and then verify and monitor the effectiveness of the security risk controls.

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