Devices

Court Accepts FDA View in Device Preemption Case

The 3^rd Circuit Court of Appeals has followed views submitted by FDA in an amicus brief in a case involving allegations that the manufacturer of an artificial hip promoted the device illegally. A Washington Legal Foundation (WLF) online Legal Pulse says that on the question of whether the suit was preempted by federal law, FDA emphasized that the Federal Food, Drug, and Cosmetic Act expressly preempts state law claims that would impose “different or additional requirements on approved devices.” The agency said that since the plaintiff was challenging the safety and effectiveness of an approved device, any state law claim would impose additional requirements and was thus preempted.

In a 3/1 opinion, the 3^rd Circuit agreed with FDA and said the plaintiffs’ claims “would impose non-parallel state law requirements” and were preempted.

“The 3^rd Circuit’s decision is just another example of the importance of FDA’s role as uniform regulator,” WLF says. “Hopefully FDA’s current leadership will continue to lead the way in ensuring the consistency that all consumers expect when making choices about their medical products.”

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