Devices

Respirator Decontamination Webinar

A 7/7 CDRH Webinar covered decontamination systems for respirators, including specific methods for decontamination, evidence of potential effectiveness, and best practices and common challenges in emergency use authorization request submissions. The Webinar focused on N95 respirators, the disposable facepiece filtering respirators that cover a user’s airways or nose and mouth and offer protection from particulate material and an N95 filtration efficiency level.

CDRHer Binita Ashar said a decontaminated respirator should only be used when there are insufficient supplies of newly approved cleared or authorized respirators. She said FDA has authorized nine decontamination systems for high-level, tier-one decontamination,

CDRH assistant director for the reprocessing and personal protection team Captain Elizabeth Claverie-Williams said a recent agency guidance “was developed to communicate a recommended framework to our stakeholders who are developing microbicidal processes intended to make respirators safe for subsequent uses.” The guidance gives recommendations for submissions of an evidence-based approach to decontamination and bioburden reduction systems.

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