Devices

Over 200 Covid Tests Authorized Through EUA

CDRH Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel says FDA has authorized over 200 SARS-CoV-2 tests in the emergency use authorization pathway. Speaking on an 8/5 virtual town hall on development and validation of coronavirus tests, Stenzel said there are “hundreds of EUA applications in house.”

According to Stenzel, FDA is operating on an honor system, expecting that companies submitting tests have done their validations well and have acceptable performance.

He also addressed pooling of tests on the Webinar, noting that in all cases pooling appears to decrease the percent positive rate and thus low positives are going to be missed. He said that is a given with pooled tests but FDA wants to limit the misses to an acceptable level. Stenzel said updated agency templates call for a sensitivity/PPA (positive agreement) relative to single tests on the platform of 85%.

“You can pool up to as many as you want as long as you hit that number,” he said. “We are asking for an even distribution of levels of positivity, so a good range of low positive and high positives, up to high positives…. We’ll work closely with you to make sure that that distribution is good.”

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