Devices

FDA Mobile Medical App Software Policy

FDA has published a guidance, Policy for Device Software Functions and Mobile Medical Applications, to inform manufacturers, distributors, and other entities about how the agency intends to apply its regulatory authorities to select software functions intended for use on mobile platforms or general-purpose computing platforms. “Given the rapid expansion and broad applicability of software functions deployed on mobile or other general-purpose computing platforms,” the document says, “FDA is issuing this guidance document to clarify the subset of software functions to which FDA intends to apply its authority.”

The guidance says that consistent with the agency’s existing oversight approach that considers the functionality of the software rather than the platform, it intends to apply its regulatory oversight to only those software functions that are medical devices and whose functionality could pose a risk to a patient’s safety if the device were to not function as intended.

The guidance contents are Introduction, Background, Definitions, Scope, Regulatory Approach for Device Software Functions, Regulatory Requirements, and six appendices.

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