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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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More from United States

US FDA Unveils Plans To Consolidate Support Services

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 
• By Brian Bossetta

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By Elizabeth Orr

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.

Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By Sue Sutter

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.

More from North America

FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 
• By Brian Bossetta

The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.

Somnee AI-Powered Sleep Wearable Raises $10M Seed Round

 
• By Natasha Barrow

The $10m seed extension funding round will be used to launch the second-generation wearable headband with the added SmartSleep AI operating system.

‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 
• By Brian Bossetta

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.