Devices

Multi-Component Preemption Based on Each Component: Court

The 3^rd Circuit Court of Appeals has issued the first appellate decision that preemption for multi-component medical devices should be addressed on a component-by-component basis. Attorney Michelle Yeary (Dechert) says the ruling came in an appeal from a Pennsylvania federal court decision in a case involving a Smith & Nephew hip replacement multi-component device.

Yeary says the question of how to apply PMA-preemption to a multi-component device is important because surgeons engaging in off-label use mix and match parts with different regulatory backgrounds.

The 3^rd Circuit found that the plaintiff’s negligence, strict liability, and breach of implied warranty claims were all preempted under the Supreme Court’s Riegel decision. The plaintiff argued that a preemption determination should be made by looking at the device that was implanted as a whole. But the company said the proper focus would be to look at the device component with which the plaintiff took issue.

The court found that the Federal Food, Drug, and Cosmetic Act defines “device” to include components, parts, and accessories. It also found that the law’s off-label provisions specifically acknowledge that a physician can and will use components separately from the system for which FDA approved use. The court also acknowledged that FDA says that a device is not limited to the device as a whole, but includes its components. And the agency is charged with assuring the safety and effectiveness of components as well as finished devices, the court said.

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

Read more

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