Devices

CDRH Denies Petition Seeking 510(k) Exemption

CDRH has denied a Germaine Laboratories petition that sought an exemption from premarket notification requirements for “method, metallic reduction, glucose (urinary, non-quantitative)” devices that are in reagent tablet form. Currently, the devices are in Class 2 and referred to as “copper reduction tablet tests.” The devices are intended for use to measure glucose in urine.

The petition argued that the tablet form of the device, Clinitest Reagent Tablets, does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device. In its response, FDA disagreed and cited numerous reports of injuries, including possible deaths, resulting from exploding bottles due to heat and erroneous consumption of the device.

FDA said in its response that premarket notification is necessary to provide safety and effectiveness assurance of the devices classified as copper reduction tablets tests, and it assigned the product classification code JIM.

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