Devices

Input Requested on Down Classifying Certain Class 3 Devices

FDA is seeking comments on a final set of PMA product codes that have been identified under a two-year retrospective review as candidates for reclassification, a reduction in premarket data collection through reliance on postmarket controls, or a shift in data collection from premarket to postmarket. Analyzing the Class 3 “procodes” was intended to “determine if current classifications and data collections remain appropriate for determining a reasonable assurance of safety and effectiveness,” an agency notice says. “As our understanding of the technology associated with individual medical devices has increased and we have a better understanding of the risks associated with the technology of each device, our understanding of the type and amount of data that are needed to demonstrate a reasonable assurance of safety and effectiveness also evolves. We use this evolution in our understanding to require the least burdensome amount of data necessary to evaluate device effectiveness, following the least burdensome provisions of the FD&C Act (section 513(a)(3)(D)(ii).” To view a list of the procodes reviewed, click here.

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