Devices

Device Software Submission Guidance

FDA has published a guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, to give the industry information about the documentation the agency recommends be included in premarket submissions for software devices, including standalone software applications and hardware-based devices that incorporate software. The document is a result of ongoing efforts to state agency recommendations more clearly and ensure they remain current as technology advances, FDA says. It combines two previous guidances into one.

The guidance contains an Introduction, Least Burdensome Approach, Scope, Relationship to Other Documents, Terminology, Level of Concern, Determining Level of Concern, Software-related Documentation, the Special 510(k) Program, the Abbreviated 510(k) Program, Additional Topics, and References.

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

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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