Devices

Bipartisan Bill Introduced on Device Cybersecurity

Senators Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) have introduced the Protecting and Transforming Cyber Health Care (PATCH) Act that would implement critical cybersecurity requirements for device manufacturers applying for premarket approval through FDA. The bipartisan PATCH Act would “ensure that innovative medical technologies are better protected from cyber threats and keep personal health information safe while also finding new ways to improve care,” Baldwin said in a release. U.S. Representatives Michael C. Burgess (R-TX) and Angie Craig (D-MN) introduced the companion legislation in the House last month.

According to the lawmakers, the legislation would:

Allow for the manufacturer to design, develop, and maintain processes and procedures to update and patch the device and related systems throughout the lifecycle of the device.
Establish a software bill of materials for each affected device that will be provided to users.
Require the development of a plan to monitor, identify, and address post market cybersecurity vulnerabilities.
Request a coordinated vulnerability disclosure to demonstrate safety and effectiveness of a device.

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