Devices

Rep. Murphy Wants FDA Artificial Intelligence Info

Rep. Gregory Murphy (R-NC), a practicing urologic surgeon and co-chair of the Congressional Doctors Caucus, is asking FDA for information on its approach to artificial intelligence (AI) in medicine and the tools and authorities it may need. In a 1/3 letter to FDA commissioner Robert Califf, Murphy says it has been estimated that AI could eliminate up to $360 billion in healthcare spending in the United States. He says the savings “could be realized from administrative cost reductions, rooting out inappropriate medical care, and increasing labor productivity.”

He notes that although several proposals to establish artificial intelligence regulatory frameworks have been introduced in both chambers of Congress, no “serious effort” has been made by either body to pass comprehensive legislation.

Murphy says FDA has cleared over 500 such devices using current 510(k) clearance/premarket approval (PMA) frameworks. But, he cautions, unclear liability guidance and overlapping regulatory governance responsibility are undermining product manufacturers and will hinder patients’ access to emerging therapeutic technologies.

“I am committed to ensuring FDA has the authority and tools it needs to cultivate an environment that advances innovation in the development and use of artificial intelligence in health care to fortify the doctor-patient relationship and improve care outcomes through lower costs, increased patient convenience, and personalization,” Murphy writes. To that end, he asks for the agency’s responses to these points:

the actions FDA is taking to prepare for a rapid increase in 510(k) and PMA requests for ML (machine learning) and AI devices;
whether the agency plans to strengthen its 510(k) Third-Party Review program for less complex products to free staff time;
whether the agency supports voluntary alternative pathways for the approval of AI products and integrated devices;
whether the agency supports a liability safe harbor for AI-enabled devices and physicians using such devices in the context of continued compliance with post-market surveillance programs; and
FDA’s views on the role that organizations such as medical licensing bodies, hospital credentialing boards, and medical societies should play in establishing AI standards of use.

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