FDA an important step closer to ISO 13485:2016
ISO 13485:2016 is the well established international quality standard for manufacturers of medical devices. With the US market increasingly looking attractive for UK and EU manufacturers, the FDA has always been walking to a different step with their 21 CFR Part 820.
On 31st January 2024, a key move was made by the FDA in issuing their final rule amending the 'Quality System Regulation' (QSR) to better align with ISO 13485:2016. Instead, the QMSR becomes the new name as the 'Quality Management System Regulation', so hello QMSR and farewell 'QSR'.
The date to work to is 2nd February 2026 for enforcement of the QMSR. We know that 'tempus fugit' , so manufacturers need to use the 2 year period, starting from now. However, better alignment around the world should lead to simplification, lower cost for compliance, and more time efficiency for medical device manufacturers.
So what is the difference? In short, this means that the new FDA QMSR converges even more with ISO 13485:2016, and will directly reference requirements from it, changing the way that 21 CFR Part 820 appears once the QMSR is brought into effect.
All in all, this is good news for the medical device industry.
MBBS., Masters in Medical Science and Technology.MMST(IIT KHARAGPUR).
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