Zdrowie i gospodarka · 02/05/2011

Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled "Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." The recommendations in this guidance are intended to improve the safety and effectiveness of devices with processing or reprocessing labeling. This draft guidance is not final; nor is it in effect at this time.