Devices

CDRH Resuming Non-Covid IVD Pre-Submission Reviews

CDRH says that as of 6/1 it plans to again accept all non-Covid in vitro diagnostic (IVD) pre-submissions. In an FDA Voices online post, CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel say that due to the continued elevated workload related to Covid, it is likely that the IVD pre-submissions will initially be reviewed under an extended timeline.

News of the resumption of non-Covid IVD pre-submission acceptance is included in an update on the Center’s Covid-19 submissions and workload. It says CDRH continues to manage a high volume of conventional premarket submissions and requests for emergency use authorization (EUA).

The agency has granted EUAs or traditional marketing authorizations to over 2,300 medical devices for Covid-19, the update says.

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