Devices

FDA Denies Petition on Scrubs as Medical Devices

FDA has denied a petition submitted on 12/11/2020 by attorney James Czaban (Loeb & Loeb) asking that the agency “clarify and confirm circumstances … under which garments generally known as ‘scrubs,’ which are worn as daily-wear uniforms by a wide variety of employees in various healthcare settings, are not ‘devices’ within the meaning of the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations, and that such products also are not devices if they incorporate an antimicrobial component solely for purposes of protecting the garment.” In its response, FDA says gowns and other apparel would broadly be regulated as a medical device when they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease or when they are intended to affect the structure or any function of the body.

FDA says its intended use decisions are product-specific and sponsors who are uncertain about a specific product and its intended use should seek agency feedback. The response says the agency does not believe additional rulemaking, guidance, or an advisory opinion is warranted in response to the issues raised in the petition.

The letter says Czaban’s third requested action is not a proper subject for a citizen petition because it asks the agency to refrain from taking enforcement action.

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