Devices

Implementing Cybersecurity Provision in Spending Bill

CDRH Office of Strategic Partnerships and Technology Innovation director Suzanne Schwartz says the agency is working to implement provisions in the recently-approved omnibus spending bill giving FDA authority to require medical device manufacturers to address cybersecurity issues. In an online interview with HealthcareInfoSecurity, Schwartz said the agency has spent several years urging voluntary action to address cybersecurity in medical devices and is “thrilled” to receive the legal authority to require that companies address the issue.

Asked how FDA is implementing the new law, Schwartz said the agency is currently conducting a legal analysis of the bill’s provisions to determine how it will need to move forward. She said a 4/2022 premarket draft guidance that is being finalized likely will cite provisions from the law.

Schwartz says the $5 million included in the bill for medical device cybersecurity will go a long way in helping FDA to hire additional expert staff to work on submissions. More resources likely will be needed in the future, she said, but the agency appreciates the initial funding that will get things started.

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