Devices

CDRH Seeks Input on Cybersecurity Servicing Practices

CDRH has released for comment a discussion paper, “Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities,” seeking input from groups and individuals outside FDA on the shared responsibility. Four areas identified in the paper are privileged access, identification of cybersecurity vulnerabilities and incidents, prevention and mitigation of cybersecurity vulnerabilities, and product lifecycle challenges and opportunities.

FDA has scheduled a 7/27 Webinar on that discussion paper and on a recent draft guidance on remanufacturing of medical devices.

A Webinar notice says it (1) will help clarify whether activities performed on devices are likely remanufacturing, (2) is intended to convey the agency’s current thinking on applicable definitions and clarify the regulatory requirements applicable to remanufacturers, and (3) will outline specific cybersecurity challenges and opportunities associated with medical device servicing.

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