The Food and Drug Administration (FDA or agency) is issuing this draft guidance to provide guidance to industry and FDA staff about the expectations for quality management system regulation (QMSR) requirements for premarket submissions once the final rule amending 21 CFR part 820 goes into effect.
The medical device current good manufacturing practice (CGMP) requirements of the QMSR have been updated to align more closely with the international consensus standard for devices by incorporating by reference an international standard specific for device quality management systems (ISO 13485:2016).
When final, this guidance is intended to assist medical device manufacturers in preparing and maintaining the Quality Management System (QMS) and other information required in premarket submissions stemming from the QMSR.