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FDA pushes back timeline for harmonising QSR with ISO 13485

  • Posted by: inetika
  • Category: GLOBAL NEWS

The US Food and Drug Administration (FDA) has revised again the planned timing of release of the Agency’s draft Quality System Regulation (QSR), which is aimed to harmonise FDA requirements for medical device manufacturers with the international quality system standard ISO 13485:2016.

FDA’s first target date, announced in May 2018, was April 2019, revised to September 2019, but now delayed again by a further six months until April 2020.

Industry has already waited nearly 30 years since the inception of the Global Harmonisation Task Force (GHTF) proclaimed its aim of reducing regulatory burdens on manufacturers by harmonising quality system and submission standards, so it will surprise no one that further delays are now being encountered.

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