Devices

Low PCCP Use Could be ‘Missed Opportunity’: Study

Researchers from several universities say that low use of predetermined change control plans (PCCPs) for AI-enabled medical devices could be a missed opportunity for improving device performance. The researchers report on a cross-sectional study describing PCCP use among AI-enabled medical devices and the comprehensiveness of public reporting documenting PCCPs that was published in JAMA Health Forum. The researchers say that PCCPs allow manufacturers to quickly implement device modifications while prespecifying plans for mitigating risk.

The study found that only 5% of AI-enabled medical devices had an FDA-authorized PCCP during the 2023-2025 study period. The researchers said they observed a modest increase in PCCP use starting in 2025. “Among devices with PCCPs,” the report says, “public reporting of PCCP elements was reasonably high: nearly three-quarters reported all FDA-recommended elements. Additionally, many manufacturers used multiple methods to communicate updates to users.”

The researchers found that the PCCP authorization process was generally accessible to manufacturers with differing levels of experience; experience with AI-enabled devices was not associated with PCCP use, nor did manufacturers undergo meaningfully different review times when submitting a PCCP.

“Nonetheless,” they conclude, “low overall adoption indicates that there remain unidentified barriers to PCCP use or that certain AI-enabled devices may simply be unamenable to prespecified design changes that preserve safety and effectiveness.”

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