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Benefit-Risk Calls On PMAs Based On Patient Pluses Versus Adverse-Event Chances, Guidance Says

 
• By Sue Darcey

In an Aug. 24 guidance, US FDA says it's swayed by what it and patients believe are the magnitude and duration of benefits of a device or diagnostic, versus how troublesome any adverse events might be, and patient tolerance for them. The document describes factors the agency relies on when making risk-benefit decisions about PMA submissions and de novo classifications. Further, the agency expects sponsors and staff to recalculate the benefits and risks at every step along the device development process – and beyond.

A final benefit-risk guidance highlights factors FDA takes into consideration when evaluating device PMA and de novo classification submissions. The document instructs both the sponsor and agency staff to examine the potential magnitude, duration and clinical impact of device and diagnostics, and weigh those against the patient's tolerance for, and actual risks of, a new device or diagnostic.

Released Aug. 24, the new guidance supersedes an older version that FDA released in March 2012, and a...

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Ultrahuman Launches Home Health Monitoring

 
• By Natasha Barrow

Ultrahuman seeks to “create an environment that aligns with our bodies" by linking environmental parameters collected by Ultrahuman Home to health physiology, measured by the Ultrahuman Ring Air.

FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
• By Elizabeth Orr

The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.

US House Budget Sets FDA FY26 Funding At $3.2B

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

Panel: FDA’s Home Healthcare Initiative Holds Promise, But Challenges Remain

 
• By Elizabeth Orr

During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.

More from North America

J&J MedTech Launches KINCISE 2 Surgical Automated System In US

 
• By Natasha Barrow

The KINCISE 2 Surgical Automated System aims to “reduce the physical burden on surgeons compared to manual impaction in primary and revision hip and revision knee replacement procedures,” said J&J MedTech.

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

‘Dawn Of FDA’s AI Era’ Has Arrived. Makary Announces Early Implentation Of ‘Elsa’ Platform

 
• By Brian Bossetta

US FDA Commissioner Marty Makary says the agency’s generative AI tool ‘Elsa’ will allow employees across the FDA to work more efficiently. The commissioner says Elsa’s launch comes ahead of schedule following a successful pilot program.