Devices

Update on Software as a Medical Device Pilot

FDA has released an update on its ongoing pilot to develop a medical device software precertification program that notes FDA is leaning toward a “question-based approach” for its tested streamlined review which it believes will lead to a structured and consistent “ software as a medical device (SaMD)” definition in alignment with an International Medical Device Regulators Forum (IMDRF) framework to ensure a globally harmonized approach. The update says that the pilot continues working on a framework and mechanics for collecting real-world performance data. “This effort includes exploring less reliance on solely manual collection of information and more focus on ways to use technology, such as automated remote access to digital data, to collect SaMD product information once it is on the market,” it says. FDA says it is also continuing to explore how to leverage and use information and data from available external sources that would allow it and precertification companies to be more efficient and streamlined without compromising product safety and effectiveness.

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