Devices

CDRH to Roll Out ‘Digital Health’ Unit

CDRH is planning to establish a centralized digital health unit within the Office of the Center Director to ensure “proper coordination and consistency across the agency” for device-related apps and “software as a medical device (SaMD) issues.” Speaking last week at MedCon conference at Xavier University, CDRH associate director of digital health Bakul Patel said the unit would provide technical expertise on digital health products, and the Center would explore opportunities to establish premarket approval/clearance pathways tailored for the unit that will rely on “real world evidence while incorporating principles established under international harmonization.”

The unit is mandated in the latest medical device user fee program that will go into effect 10/1. The unit will provide expertise, when appropriate and when requested by device makers, for premarket submissions that include SaMD, software in medical devices, interoperable devices, or otherwise incorporate novel digital health technologies, according to Patel. In addition to providing digital health expertise, he said the unit will focus on:

Software life cycle management processes
Mobile medical application interoperability
Cybersecurity
Wireless issues
Cloud management
Machine learning/artificial intelligence

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