FDA Exempts Certain Unclassified Devices From Premarket Notification

February 8, 2019

The FDA issued a revised guidance to say that it intends to exempt certain unclassified devices from premarket notification requirements.

The guidance lists six device categories — ear, nose and throat devices, gastroenterology-urology devices, general and plastic surgical devices, neurological devices, obstetrical and gynecological devices and physical medicine devices — that should be exempted.

Products waived from the premarket notification requirements include hemorrhoid cushion devices, fertility diagnostics and a spine curvature device.

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