Devices

Many AI/ML Framework Comments Lack Evidence: Study

University of Oxford researchers say their review of comments on a proposed FDA regulatory framework for modifications to artificial intelligence and machine learning-based software as a medical device found that 63% of the comments came from parties with financial ties to industry and 86% of comments did not cite any scientific evidence. The results of their study were published in BMJ Open.

“We found no evidence that submitters without a financial interest were more likely to cite scientific evidence or contribute more comprehensive comments,” the researchers say. “… There were far fewer academic submissions than those from industry.”

The article says the researchers recommend that FDA request a statement of interests in comments to help further determine the extent of conflicts of interest in future public consultations. They also say the agency could reject anonymous comments unless there is a clear reason that anonymity would improve comment quality. And they call on FDA to encourage more academic participation and to call for the use of scientific evidence in public comments.

The report’s lead author, postdoctoral scientist James Smith, said in a university statement that the process for development regulations “is, roughly, to get feedback from the public on its initial proposal, make changes and draft regulations or guidance, get more feedback, and eventually finalize. Anyone can comment but at present there is no requirement, or even recommendation, to disclose any conflicts of interest. Also, FDA states that it looks for ‘good science’ in comments but it is not a requirement to incorporate it. Our goal was to look at the extent and disclosure of financial ties to industry and the use of scientific evidence.”

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