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Assessing Patient Impact From Recalls Often A Judgment Call, US FDA Says

 
• By Elizabeth Orr

Industry participants on an FDA-convened webinar asked for further guidance on how to evaluate the effects enforcement actions might have on patients and the public health. The webinar was organized to discuss a recent FDA draft guidance on benefit-risk considerations for post-market decisions.

Recent US FDA draft guidance on benefit-risk considerations for enforcement actions doesn’t give specific standards for how manufacturers should weigh the potential public impact of a recall. But that could change if comments on the draft ask for the information, a device center official said during a July 11 webinar discussing the draft document that was issued in June.

Multiple participants in the webinar asked for more information on how companies should evaluate what potential effect an enforcement action...

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More from United States

Altaviva Approval A Big Win For Medtronic And Millions Struggling With Bladder Control

 
• By Brian Bossetta

The US FDA has approved Medtronic’s Altaviva, a subcutaneous device implanted near the ankle that offers a new treatment option for adults with urge urinary incontinence.

FDA Oversight Still Falling Short on Women’s Safety, Advocate Finds

 
• By Elizabeth Orr

Device safety advocate Michelle Llamas says the FDA’s device review system leaves women at risk, citing weak oversight of 510(k) clearances, delayed safety warnings, and underrepresentation in trials. Her updated report urges stronger monitoring, transparency, and safeguards.

Pair Of Safety Alerts In Line With Broader FDA Enforcement Crackdown

 
• By Brian Bossetta

The US FDA issued two safety alerts concerning associated risks from unauthorized medical devices. The alerts are consistent with a larger effort to clamp down on consumer goods that have not been subject to agency review.

CMS Announces $50B In Grants For Rural Health Transformation

AdvaMed has praised CMS’ Rural Health Transformation Program, which will allocate $50 billion over five years to enhance rural healthcare. States can apply for grants by Nov. 5 to develop sustainable healthcare systems and improve patient outcomes.

More from North America

CMS Announces $50B In Grants For Rural Health Transformation

AdvaMed has praised CMS’ Rural Health Transformation Program, which will allocate $50 billion over five years to enhance rural healthcare. States can apply for grants by Nov. 5 to develop sustainable healthcare systems and improve patient outcomes.

Mental Health The Focus Of Upcoming Digital Health Advisory Committee Meeting

 
• By Brian Bossetta

The US FDA will hold a public meeting of its Digital Health Advisory Committee in November to focus on generative AI-enabled medical devices to treat mental health.

Blood Sugar Spike Risk Leads To Recall Of Tandem Insulin Pumps

 
• By Brian Bossetta

Tandem Diabetes Care initiated a recall last month of several t:slim X2 insulin pumps due to a “malfunction 16” error that can cause the pumps to shut down. The problem is triggered by wiring within the device speaker.