Zdrowie i gospodarka · 25/04/2001

Medical Device Inspection Evaluation Report; Availability

The Food and Drug Administration (FDA) is announcing the availability of a report entitled "Medical Device Inspection Evaluation Report." The report describes the outcomes of the Medical Device Inspection Evaluation pilot conducted between March 1, 1999, and February 29, 2000. The report was prepared by the University of California at Irvine Statistical Consulting Center from the information received on the evaluation forms submitted by medical device manufacturers who were inspected for their compliance with the quality system/good manufacturing practices (QS/GMP) during the time of the pilot.