Devices

FDA Software Functions Guidance Explained

Two medical device technical experts at Hyman, Phelps & McNamara say an 11/4 FDA draft guidance describes the recommended documentation that a sponsor should include in premarket submissions for medical device software functions. Writing in their firm’s FDA Law Blog, the two say the draft, when finalized, will replace a 5/11/2005 guidance. FDA is receiving comments on the draft until 2/22/22.

The new draft applies to both software in a medical device and software as a medical device, the post says, with a scope that is essentially the same as the 2005 guidance.

“The most obvious update to the new draft guidance is the shift from three to two categories for determining which software documentation to include in a premarket submission,” the authors write. “According to the 2005 software guidance document, FDA used Major, Moderate, or Minor Level of Concern to determine the recommended documentation for software. In the new draft guidance document, FDA introduced four risk-based factors to help determine the device’s documentation level — either Basic Documentation level or Enhanced Documentation level.”

The authors say other significant changes include FDA’s details around what is expected for system and software architecture and risk management. The agency also updated the guidance for artificial intelligence/machine learning software devices.

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