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

Executive Summary

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.

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