Zdrowie i gospodarka · 12/08/1999

``Draft Compliance Program Guidance Manual: Inspection of Medical Devices;'' Availability

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance document entitled ``Draft Compliance Program Guidance Manual: Inspection of Medical Devices.'' This revised draft compliance program provides guidance to FDA staff for the enforcement of four medical device postmarket regulations: The quality system (QS) regulation, which includes coverage of sterilization process validation and the use of the guidance on quality systems inspections technique (QSIT); medical device reporting (MDR); medical device corrections and removals; and medical device tracking requirements. This revised draft guidance is intended to represent the agency's current thinking on the inspection of medical device manufacturers, and it is neither final nor in effect at this time.