Devices

Device Regulators Guide on Change Control Plans for Device Software

The International Medical Device Regulators Forum (IMDRF), of which FDA is a founding member, has published a final document outlining global principles for Predetermined Change Control Plans (PCCPs), a regulatory approach intended to streamline updates to medical device software while maintaining safety and regulatory oversight. The “Essential Principles and Content of Predetermined Change Control Plans” document was prepared by the group’s software as a medical device working group,

The framework describes how manufacturers can seek advance authorization for specific, planned software modifications that would otherwise require separate regulatory review before implementation. Under a PCCP, manufacturers would identify the planned changes, establish protocols and acceptance criteria for implementing those changes, and assess their potential impact on the device's safety and performance.

IMDRF said the approach is designed to help regulators keep pace with the rapid evolution of software-based medical devices by allowing certain pre-approved updates to be deployed more quickly. The group said PCCPs could improve patient access to software enhancements, reduce administrative burdens for manufacturers and regulators, and encourage earlier collaboration between industry and regulatory agencies.

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