Devices

New FDA Cybersecurity Safeguard Requirements

Attorneys Dominick DiSabatino and Audrey Crowell (Sheppard Mullin) say a recent FDA guidance and FAQ document explain new medical device cybersecurity safeguard requirements from the Consolidated Appropriations Act of 2023. The attorneys cover which submissions are subject to the new cybersecurity requirements, what the new requirements are, and how the new requirements fit into the current regulatory scheme.

Under the law, manufacturers of covered cyber devices must demonstrate compliance with each of these requirements in all pre-market applications submitted after 3/29 for products that qualify as cyber devices:

submit a plan to monitor, identify, and address, as appropriate, in a reasonable time, post-market cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures;
design, develop, and maintain processes and procedures to provide a reasonable assurance that the device and related systems are cybersecure, and make available post-market updates and patches to the device and related systems; and
provide a software bill of materials, including commercial, open-source, and off-the-shelf software components.

FDA has said it will exercise enforcement discretion until 10/1, presumably to give industry time to adjust to the new requirements, the attorneys say.

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