Devices

FDA Heading to ‘Sliding Scale’ of Medical Device Evidence: Lurie

Former FDA associate commissioner Peter Lurie, who now heads the Center for Science in the Public Interest, is expressing concern that with its emphasis on being “first” in medical device approvals and acting on safety signals, FDA is laying the groundwork for a “sliding scale” of medical evidence that will leave patients even more uncertain about device safety and effectiveness. Referring to a draft guidance that would ease pre-market testing standards for some devices in exchange for companies conducting larger follow-up studies, Lurie told the Associated Press that the guidance “is basically a ‘come hither’ to industry, inviting them to ask FDA for lower standards of evidence.”

FDA’s medical device standards are still considered among the highest in the world, AP says. But Lurie said that by trying to outpace other countries with less stringent requirements, the agency has opened the door to lowering its own standards to achieve its goal.

Recently, FDA announced it was looking at ways to modernize the 510(k) process that would allow it to more readily incorporate new technologies that improve the safety and performance of medical devices into new predicates to serve as benchmarks for future clearances. And it said that it wanted to be the world leader in finding medical device safety signals and act upon them.

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