Devices

FDA Grants ‘Emergency Use’ for 2 Antibody Tests

FDA has granted emergency use authorizations to two Covid-19 antibody tests — Chembio Diagnostic System’s DPP COVID-19 IgM/IgG System and Ortho Clinical Diagnostics’ Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. The two serology tests will aid in determining whether somebody has already been exposed to the virus and may have immunity.

Serology test accuracy is getting increasing attention at CDRH, according to Center Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel. Because of accuracy concerns, Stenzel said that FDA is collaborating with other agencies to create an interagency program to help address and verify test accuracy (see earlier story).

On 4/12, FDA commissioner Steve Hahn addressed antibody tests on ABC’s “This Week With George Stephanopoulos.” Hahn said that there are a number of tests “on the market that we haven't validated, that we haven’t looked at those data. There is a U.S. government effort to look at some of those tests and to be able to allow that validation to occur.” Hahn also acknowledged FDA has evaluated reports from other countries about their antibody tests not being accurate. “I think it's really important for the American people to know that we need tests that are accurate, reliable and reproducible; that’s what FDA does in a science and data-driven way,” he said.

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