Devices

FDA Emergency Monkeypox Test Guidance

FDA has published an immediately effective guidance, Policy for Monkeypox Tests to Address the Public Health Emergency, describing the agency’s review priorities of emergency use authorization (EUA) requests for monkeypox diagnostic tests. The document also covers the FDA enforcement policies for certain diagnostic tests that are developed by and performed in a laboratory certified under the Clinical Laboratory Improvement Amendments that meets the requirements to perform tests of high complexity, provides recommendations for diagnostic test validation, describes FDA’s enforcement policies for FDA-cleared or authorized monkeypox diagnostic tests that are modified, and describes the agency’s enforcement policies for certain serology tests.

A separate FDA notice says the agency also is providing voluntary templates that test developers may use when validating a test or when submitting an EUA request.

The guidance follows a declaration by HHS justifying the emergency use of in vitro diagnostics for the detection and/or diagnosis of the monkeypox virus. Under the declaration, FDA may issue an EUA to allow the use of unapproved in vitro diagnostics or unapproved uses of approved in vitro diagnostics, the notice 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