Devices

CDRH Tech Innovation Group Now a Super Office

CDRH says its Office of Strategic Partnerships and Technology Innovation (OST) has been elevated to a super office. The new designation allows the Center to be “well-positioned and capable of adapting to and addressing future public health needs and challenges while continuing to advance the voice of patients, innovation and safety, regulatory science, and service excellence with our customers,” according to an agency notice.

For external stakeholders, OST is intended to provide leadership and strategic direction on medical device cybersecurity, digital health, standards, and patient science while providing oversight and coordination for CDRH in matters relating to public health emergency preparedness and response activities (e.g., medical device supply chain resilience and product shortage mitigation), the notice says. “Internally, in addition to providing expertise and program support in the above areas, OST directs the Center’s data, technology, and IT transformation services to ensure effective design, development, and utilization of information systems, electronic data, and analytic capabilities to optimize regulatory business processes,” it adds.

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