Devices

Webstore-USA Marketing Unapproved Covid Serology Test: FDA

FDA says its review of a Web site maintained by Orvic, doing business as Webstore-USAVan Nuys, CA, determined that the firm is marketing an unapproved Covid-19 serology test that is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of Covid-19, and thus is legally considered to be a medical device. “The product is offered for sale in the United States without marketing approval, clearance, or authorization from FDA,” a 2/26 Warning Letter says. The letter says the test is adulterated because it does not have FDA approval, clearance, or authorization.

The letter also cites the potentially serious public health risks associated with specimen collection and testing in the home versus a healthcare setting.

Webstore-USA was told to take action to address the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each action and a schedule for completing the steps.

FDA also said the firm will be added to an agency Web site list of companies that have received Warning Letters for marketing unapproved Covid products.

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