Devices

Study: AI-Assisted Device Reviews Could Reduce Recalls

A machine learning-based approach to FDA's 510(k) medical device clearance process could reduce device recalls by nearly one-third while cutting the agency's regulatory workload by more than 40%, according to a study published in Management Science. The study evaluated a proposed system that combines machine learning with human regulatory review to identify devices at greater risk of recall before they receive FDA clearance.

Researchers from Indiana University, Harvard University and Emerging Health Consulting developed algorithms to estimate recall risk using information available when manufacturers submit 510(k) applications. Their proposed framework would recommend clearance, rejection or referral for more extensive evaluation by FDA review committees.

The researchers analyzed more than 31,000 medical device submissions using data assembled from FDA and the Centers for Medicare and Medicaid Services. Compared with FDA's existing clearance practices, which the researchers associated with a 10.3% recall rate, their proposed approach produced an estimated 32.9% improvement in the recall rate and a 40.5% reduction in regulatory workload.

The findings suggest that machine learning could help FDA allocate review resources more efficiently by identifying lower-risk submissions while directing greater regulatory scrutiny toward devices with elevated recall risks.

The proposed system is a research-based approach and would require further evaluation before they could be established in routine regulatory practice, the authors note.

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