FDA’s Draft QSR: ‘Lucy’ Pulled The Football Away. Again

US Regulatory Roundup, June 2021

Hopes were raised in mid-June when the US FDA indicated it would release its draft harmonized Quality System Regulation by the end of the month. But perhaps unsurprisingly, it never came. News about the QSR – and more – topped our list of most-read Medtech Insight articles in June.

Lucy pulls the football away from Charlie Brown.
Like Lucy taunting Charlie Brown with the football, the FDA has a track record of setting a release date for the draft QSR, only to blow past it • Source: Alamy

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