Devices

FDA Promoting Covid Test Development: Shuren

Writing in an online opinion column at The Hill, CDRH director Jeffrey Shuren and Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel say the Center has authorized over 200 Covid-19 tests in just over 200 days since the first diagnostic test was authorized. “The sheer volume and variety of available tests is a testament to FDA’s support of innovative test design and our commitment to public health,” they write.

They devote much of their column to the development of testing outside a healthcare setting, such as in consumers’ homes. The article notes that the agency currently recommends that diagnostics for Covid-19 used at home should perform with at least 80% sensitivity if ordered by a healthcare professional, and at least 90% sensitivity if purchased over-the-counter for one-time testing.

“When consumers take the test over-the-counter at home, the consumers wouldn’t be advised by a healthcare professional on what to do or if they need a second test,” Shuren and Stenzel write. “Americans will use those results and make decisions about quarantining further or returning to work, school, and their community. Therefore, accurate results are particularly important.”

Shuren and Stenzel say the agency’s recommendations are only recommendations, rather than requirements, and FDA is open to alternative proposals from developers and will continue to consider them. “More significant trade-offs in test accuracy may be appropriate where the need for availability and fast results is not being met,” they add.

They conclude that the agency supports any testing proposal where, among other criteria, the benefits outweigh the risks based on sound science. They commit to continuing to work with test developers and to encourage those with novel testing ideas to reach out to CDRH by e-mail, telephone, or at the weekly test developer online town hall meetings.

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