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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 draft version dated Aug. 15, 2011. It reflects industry comments that risk-benefit analyses of devices and diagnostics need to be addressed from cradle to grave in the development process. (Also see "FDA’s Final Risk-Benefit Guidance Excludes 510(k)s, Adds De Novo Petitions" - Medtech Insight, 2 April, 2012

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