Devices

CDRH Sets Marketing Authorization Record

CDRH says that in 2023 it gave marketing authorization to 124 novel devices, excluding emergency use authorizations, the highest on record in the Center’s history. “CDRH continues to see high numbers of novel devices coming to market,” the Center’s 2023 annual report says, “with an almost five-fold increase in novel device authorizations since 2009.”

The report says that under MDUFA 5, CDRH exceeded by 20% its presubmission goal of providing written feedback to an applicant within 70 calendar days or five days before a meeting 75% of the time. It reports filling 100% of its 141 MDUFA 5 positions for FY 2023 and says it is on track to meet the FY 2024 MDUFA 5 hiring goal.

A chart in the report shows there are 257,400 different types of regulated devices listed with CDRH and 21,500 registered device manufacturing firms. There were 19,100 submissions received and 71 new or updated guidances issued. CDRH designated 167 submissions as breakthrough devices and gave marketing authorization to 29 submissions so designated.

In his report introduction, CDRH director Jeffrey Shuren says 2023 “was a transformative year at CDRH. We officially turned a corner on the Covid-19 pandemic and moved toward a more sustainable workload, including prioritizing normal review timelines for all incoming premarket submissions.”

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