Devices

FDA Denies Staple, Staplers, and Mesh Petitions

FDA has denied three 2017 and 2018 petitions submitted by Chul-Hi Park, Ph.D., Seoul, Korea, asking the agency to prevent clearance for marketing any specific devices without proof of safety and effectiveness and retroactively regulating formerly cleared specific devices to provide similar data on safety and effectiveness. The agency response says the devices referenced in the petitions include implantable staples, surgical staplers used in the lung or digestive tract, and surgical mesh.

The petitions asked FDA to require that manufacturers of the devices perform a risk analysis and provide data from those performance tests, prospectively and retrospectively, the denial letter says. Park also asked that for retrospective review FDA develop a set of standardized performance tests that manufacturers would be required to conduct, publicize, and revise labeling accordingly.

“Your petitions have not illustrated that the performance data you recommend should be required to ensure that a device’s users can use the device safely and for the purpose for which it is intended,” the agency letter says. “The petitions offer no evidence that additional risk analysis should be performed by FDA or specific performance data should be required from manufacturers. While we are denying your petitions, we appreciate the information provided and note that FDA has recently made classification changes to internal staplers making them Class 2 devices subject to special controls, and we have issued new guidance with recommendations for labeling stapler devices, to include internal staples.”

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