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Home » Off the Shelf Software for Use in Medical Devices Guidance Replaces 1999 Version
Off the Shelf Software for Use in Medical Devices Guidance Replaces 1999 Version
Incorporating off-the-shelf (OTS) software into medical devices is becoming more common but a new guidance from the FDA advises that when using prepared software from another manufacturer, devicemakers still bear responsibility for continued safe and effective performance of the device.