FDA Exempts Certain Unclassified Devices From Premarket Notification

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.