Devices

FDA No Longer Reviewing Covid LDT Emergency Use Submissions

CDRH Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel told the agency’s weekly virtual town hall session 10/7 that FDA will no longer review Covid emergency use authorization (EUA) submissions for lab-developed tests. Modern Healthcare reports that Stenzel said the change is consistent with a recent statement from HHS and also will help FDA prioritize the review process during the pandemic.

“We are currently in a different phase of the pandemic with respect to tests than we were previously,” Stenzel reportedly said, noting that FDA has authorized more than 250 tests to be run in labs, and more than 400 are offered under the agency’s notification pathway.

He said that FDA continues to prioritize review of EUA requests for point-of-care tests, home collection tests, at-home tests, tests that reduce reliance on certain types of test supplies, and high-throughput, widely distributed tests.

Stenzel reported that the change for Covid LDT tests applies to new EUA submissions and those already in the pipeline for review.

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