Devices

Regulatory Considerations for Dialysis Catheters

The Kidney Health Initiative, a public-private partnership between the American Society of Nephrology, FDA’s CDRH, academia, industry, and patient groups, intends to advance scientific understanding of kidney health and foster development of therapies for kidney diseases. The group’s Regulatory Considerations Affecting Device Approval project was designed to: (1) describe central venous catheters (CVCs) for hemodialysis; (2) identify common issues raised during reviews of FDA submissions; (3) identify the major benefits and risks of CVCs; (4) discuss recent technological advances for the devices; and (5) enumerate limitations of currently available technology requiring research or device modification.

The group says that CVCs for hemodialysis are necessary for a subset of patients with end-stage kidney disease. In an online article in the Clinical Journal of the American Society of Nephrology, a workgroup says it hopes that improved understanding of the regulatory requirements for marketing devices will help foster device iteration and innovation, and result in more effective and safe devices for patients.

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