Zdrowie i gospodarka · 03/02/2003

Medical Devices; Final Guidance on Quality System Information for Certain Premarket Application Reviews; Availability

The Food and Drug Administration (FDA) is announcing the availability of a final guidance entitled "Quality System Information for Certain Premarket Application Reviews." This guidance has been prepared by the Center for Devices and Radiological Health (CDRH), in coordination with the Center for Biologics Evaluation and Research (CBER), to assist medical device manufacturers in preparing and maintaining the quality system (QS) information required in certain premarket submissions.