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

It should come as little surprise that as of 1 July the US Food and Drug Administration had missed its latest internal deadline for releasing a draft of its new Quality System Regulation, which the agency has been harmonizing with international quality systems standard ISO 13485:2016 for more than three years.

Hopes were raised in mid-June when the FDA indicated it would release the draft rule by the end of the...

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