Devices

FDA Approvals of High-Risk Medical Devices ‘Way Down’: Post

An online Evaluate Vantage post says FDA awarded just 12 first-time PMAs and one HDE during the first six months of this year. The post says that if the agency maintains the same approval rate in the second half of the year, it will see the fewest high-risk devices reach the U.S. market since 2013.

“A different trend is apparent when it comes to low-risk novel devices,” Evaluate Vantage says. “With 14 de novo 510(k) clearances awarded in the first half of 2021, the full-year total could end up higher than that for 2020 or the year before.”

The post says CDRH had cautioned that the unprecedented Covid-19-related workload had put a significant strain on Center resources, particularly in the office that deals with in-vitro diagnostics submissions. CDRH officials had said there was a backlog of non-Covid-19 files pending review, which would likely experience delays in meeting review timelines.

While fewer devices seem to be getting approved, the article says, the speed at which the agency is reviewing those that are approved “is very respectable. The high-risk innovative devices, which must go through either the PMA or HDE routes, received approval in just over a year on average, while the low-risk products were faster still.”

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