Zdrowie i gospodarka · 8/17/1998

Off-the-Shelf Software Use in Medical Devices; Draft Guidance; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Off-the-Shelf Software Use in Medical Devices.'' This draft guidance document is not final or in effect at this time. The purpose of the draft guidance document is to describe the information that should be provided in a medical device application involving Off-the-Shelf (OTS) software. While the draft guidance document is not intended for compliance with Quality System requirements, many of the principles outlined may be helpful to device manufacturers in establishing design controls and validation plans for use of off-the-shelf software in their devices.