Devices

CDRH Hoping for ‘Normal’ Review Times

In an update on Center activities and resources, CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel say they will work in 2022 toward a gradual transition to normal review timelines from the changes that were made to accommodate staff needs for Covid-19 activities. “Our ability to reach and sustain ‘normal’ review times will depend on the course of the pandemic and adequate resources, and we appreciate your patience and understanding while we continue to respond to the public health emergency,” the two write in an online post.

The update says CDRH has issued marketing authorizations for over 1,900 medical devices for Covid-19, including 15 times more emergency use authorizations for this public health emergency than all other previous public health emergencies combined.

For the second consecutive year, Shuren and Maisel say, the Center experienced an increase in the number of “conventional” premarket submissions, receiving nearly 18,000 submissions in FY 2021. “While the number of pre-EUA and EUA submissions declined from FY 2020 to FY 2021, we still received more than 2,200 in FY 2021,” they say.

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