Devices

Guidance on Devices with Animal Source Materials

FDA has issued a guidance, Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices), to update agency policy regarding use of animal-derived material in medical device manufacturing. “The role of animal-derived material in medical devices is well-established,” the document says. “However, these materials may carry a risk of transmitting infectious disease when improperly collected, stored, or manufactured.” The purpose of the guidance is to provide further clarification and updated information on the use of International Organization for Standardization guidances. It also has recommendations for controlling the sourcing of animal tissues regarding viral pathogens and evaluating the ability of manufacturing methods to remove such pathogens from the final product. The guidance replaces an 11/6/98 guidance.

The document updates the 1998 guidance, FDA says, by addressing aspects of potential risk from using animal tissues and also includes recommendations related to viral pathogens and all transmissible spongiform encephalopathies.

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