Devices

FDA Renames, Reclassifies Needle Destruction Device

FDA has issued a final order, General Hospital and Personal Use Devices: Reclassification of Sharps Needle Destruction Device, reclassifying the needle destruction device from Class 3 to Class 2 and renaming the device type to “sharps needle destruction device.” An agency notice says a sharps needle destruction device is an alternative to conventional sharps/needle disposal containers found in home and hospital settings.

“Based on new information,” the notice says, “FDA has found sufficient information exists to establish special controls that, together with general controls, can provide a reasonable assurance of safety and effectiveness for sharps needle destruction devices,” the notice says. “FDA also believes this final order will decrease regulatory burden on manufacturers as they will no longer be required to submit a premarket approval application but can instead submit a less burdensome premarket notification before marketing this type of device.”

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