Devices

AdvaMed Device Sterilization Reg Proposals for EPA

AdvaMed says it appreciates a proposed update to the EPA emissions standards for facilities using ethylene oxide (EtO) to sterilize medical devices and offers points for the Biden Administration to consider as it finalizes the regulation. In a letter to President Joseph Biden, AdvaMed asks the administration to:

consider the potential threat to patient care if any sterilization facilities shut down;
encourage EPA to embrace technology-neutral solutions to meet new emissions targets; and
ask EPA to consider background EtO levels in ambient air and the tiny proportion of that represented by medical device sterilization EtO use.

Last year, CDRH director Jeffrey Shuren said that as EPA working to finalize the regulation, FDA was working with the industry on steps to reduce emissions and also to maintain sufficient sterilizing capacity. Shuren’s statement discussed the EtO Sterilization Master File Pilot Program for PMA holders of high-risk devices that enables certain changes between sterilization processes and facilities that reduce the amount of EtO concentrations used to sterilize without compromising safety and effectiveness. He also discussed the Innovation Challenges that he said showed encouraging progress with new strategies to reduce EtO emissions.

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