Devices

Ostar Beauty Selling Unapproved Medical Devices: FDA

FDA says Ostar Beauty Sci-Tech Co Ltd in Beijing Shi, China, is marketing several medical devices without marketing clearance or approval. A just-released 12/4/2023 Warning Letter identifies the three types of products that FDA says are adulterated because Ostar does not have an approved PMA or IDE in place for them and misbranded because the company did not notify FDA of its intent to introduce the devices into commercial distribution.

It gives examples of the claims made for the devices that establish they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease or are intended to affect the structure or any function of the body.

FDA says it is taking steps to refuse entry of the devices into the U.S. until the violations are addressed. Ostar was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.

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