FDA CGMP QMS impact

Gialandon

Registered
HI All,
FDA released the final amendment to the cGMP requirements for quality systems in February with implementation by Feb 2 2026. (unfortunately can't post a link as I don't have enough posts)

Reading through it, I can't find any new or modified requirements if you are already ISO 13485 and FDA compliant. From my quick assessment it looks like FDA has directly referenced ISO 13485 or ISO9000 in applicable areas.

As far as I can tell there is no change needed to a QMS complaint to ISO 13485 and FDA requirements. Just wanting to check I didn't miss anything?
 

yodon

Leader
Super Moderator
(with apologies to Mr. Dylan) The terms, they are a changing'. The change eliminated terms like DHF, DMR, DHR. There are generally analogous terms in 13485. I don't know if anyone will make a stink about using those legacy terms.

What's possibly more impactful, although FDA hasn't established a position, is that materials like internal audit reports and management review minutes are not explicitly excluded from an inspector's review.

There have been a few posts on this here. You might want to search on QMSR and review these discussions.
 
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