Devices

FDA Dry Heat Bioburden Reduction Enforcement Policy Explained

CDRH Office of Surgical and Infection Control Devices biomedical engineer Devashish Shrivistava says FDA has enacted an enforcement policy for bioburden reduction systems using dry heat to support single user reuse of certain filtering facepiece respirators during the Covid-19 public health emergency “to help address the urgent public health concerns caused by shortages of filtering facepiece respirators used as personal protective equipment.” Speaking during a 1/26 Webinar, Shrivistava said FDA believes that the use of a dry heat system as a bioburden reduction method to support single-use reuse of compatible respirators will not create such an undue risk where the critical (cycle) parameters and labeling elements as described in the guidance are met.

Filtering facepiece respirators that fall within the policy scope are those that do not have exhalation walls, do not incorporate a duckbill design, and do not contain antimicrobial antiviral agents, Shrivistava said.

In response to a question, Shrivistava said that the enforcement policy will be in effect only during the Covid-19 public health emergency and that the agency is developing a plan for how enforcement policy will transition after the pandemic is over. “The plan will be communicated but we do not have the details at this time,” he said.

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