Devices

More Benefits Than Risks in Excluded Software: FDA

FDA says its review of data and information from several sources indicates that there generally are more benefits than risks to patient safety and health related to software functions excluded by the 21^st Century Cures Act from the definition of a medical device. The agency’s 2020 report on risks and benefits to health of non-device software functions says the intended functions of the excluded software are summarized as (1) administrative support of a healthcare facility; (2) maintaining or encouraging a healthy lifestyle unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition; (3) serving as electronic patient records when not intended to interpret or analyze patient records; (4) transferring, storing, or converting formats, or displaying data, or (5) unless interpreting or analyzing a clinical test or other device data, providing certain types of limited clinical decision support to a healthcare provider.

The Cures Act requires FDA to publish a report every two years that examines information available to HHS on any risks and benefits to health associated with the software functions. The first report was issued in 2018.

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