Drugs

Device EtO Sterilization Transitional Enforcement Policy

FDA has issued a final guidance entitled “Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class 3 Devices.” The document articulates the agency’s stance on expected EtO changes pursuant to new Environmental Protection Agency (EPA) requirements.

The guidance provides recommendations for manufacturers whose devices are sterilized by EtO, and that might be affected by potential, actual, or temporary stop or reduction in operations at a sterilization facility, to implement certain types of sterilization site changes. The following actions are available under the enforcement policy:

PMA and Humanitarian Device Exemption holders of approved Class 3 devices sterilized by EtO may make certain sterilization facility changes prior to approval of a supplement during the transition period.
FDA is permitted to work proactively with manufacturers, developers, and other agencies to explore effective, efficient, and innovative solutions that will help maintain a strong supply of medical devices.
Expedited sterilization site changes to reduce the impact of potential, actual, or temporary operation reductions at sterilization facilities.

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