In 2018, the US agreed to harmonize its domestic good manufacturing practices with agreed-to international standards in accordance with the Medical Device Single Audit Program (MDSAP). On Feb. 23, the Food and Drug Administration (FDA) made its contribution to that effort by publishing a proposed harmonization rule for medical device quality management systems (QMS) standards. […]

In 2018, the US agreed to harmonize its domestic good manufacturing practices with agreed-to international standards in accordance with the Medical Device Single Audit Program (MDSAP). On Feb. 23, the Food and Drug Administration (FDA) made its contribution to that effort by publishing a proposed harmonization rule for medical device quality management systems (QMS) standards. […]