Devices

Sen. Cassidy Challenges FDA on CDS Oversight

Sen. Bill Cassidy (R-LA) is calling on FDA to justify its decision to expand its oversight over clinical decision support (CDS) software beyond its statutory authority. In a letter to FDA commissioner Robert Califf, Cassidy says the agency’s 9/2022 final guidance that seeks to regulate CDS as a medical device “threatens to undermine the effective use of these tools.”

According to Cassidy, Congress excluded CDS software from being categorized as a medical device in the 21st Century Cures Act. But, he says, the agency issued updated policy classifying CDS software as a medical device.

“This change,” he says, “subjects software developers, many of them small healthcare practices, to an extensive and costly regulatory process that is unnecessary for these tools. FDA chose to make this policy change without giving stakeholders the opportunity to provide feedback on the potential negative impacts of this policy.”

The letter asks Califf to provide additional information on why FDA ignored Congress’ direction by expanding its regulatory authority over CDS software. He also asks for an explanation of why the agency did not seek stakeholder input in advance of the policy.

“This guidance unnecessarily calls into question the safety of these tools and expands the universe of entities regulated by FDA, many of which are small provider practices who have developed their own CDS tools,” Cassidy concludes. “FDA has failed to raise specific safety concerns with CDS software that would justify expanding FDA’s oversight over these tools. FDA’s guidance not only runs contrary to an explicit congressional directive but may jeopardize access to advanced tools that improve patient care.”

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