Devices

Captain’s Cloth Selling Unapproved KN95 Masks: FDA

FDA says its review of the Web site maintained by Captain’s Cloth, Laguna Niguel, CA, determined that the firm is marketing KN95 face masks manufactured by Lianyungang Manai Protective Equipment Co. Ltd. that are offered for sale in the U.S. without marketing approval, clearance, or authorization from FDA. A just-released 7/2 Warning Letter says the products are adulterated because they are not approved and misbranded because the company did not notify the agency of its intent to introduce the devices into commercial distribution.

The letter says the devices also are misbranded because the labeling is false or misleading.

“Display of the FDA logo on packaging and near images of and information about the respective products, combined with statements about having active status with FDA, is misleading because such information implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the products and/or establishments,” the agency says. “Such representations are especially concerning from a public health perspective because consumers rely on information provided by sellers to determine whether to purchase a device and your presentation conveys the misimpression that the products have been reviewed and approved by FDA.”

Captain’s Cloth was told to respond with a list of specific steps taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the work.

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