FDA & ISO DMR/MDF vs. “Design Output”

FDA & ISO DMR/MDF vs. “Design Output”

April 1, 2019

FDA & ISO DMR/MDF vs. “Design Output”

Remember that the DMR is intrinsically linked to the design control process.  The DMR is by formal definition a design output (see my preceding blog post).  It unequivocally lives and breathes in direct relationship to the design control process.  A properly-maintained DMR never becomes decoupled from the design control process.  Indeed, decoupling the DMR and the design control process is a certain recipe for an FDA 483.


As the product life-cycle evolves and DMR changes are needed, they by regulation are not allowed to happen apart from the design change requirements of the design control process.  Even more eye-opening is that, if there is ever a change to design outputs (and thus the DMR), then it must always be paired with corresponding design verification and perhaps also design validation.  Oftentimes, this in addition means there was a change in the underlying design inputs.


Another way to say all this is that if there is ever a change to the DMR, then it inherently means there was a “design change”.  That is the reason FDA doesn’t permit us to maintain the DMR independent of the design control process.  The associated use of a general (e.g., 21 CFR 820.40) document control process may create the impression that this is independent of 820.30 design controls; however, that is not the intent of the design control and DMR regulations.


For example, FDA has stated that “…Post-production design changes [which would include DMR changes] require the firm to loop back into the design controls of Section 820.30 of the regulation…[Emphasis added by ComplianceAcuity].  Similarly, FDA has also clarified that, “…The design change control section is linked to and is redundant with Section 820.70(b) Production and process changes of the regulation…” [though this particular citation focuses solely on the manufacturing section(s) of the DMR].  For additional insights about design changes and thus how the DMR must be maintained in direct correlation with design controls, check out my corresponding related blog post.


If you are careful to assure that your DMRs don’t wander away from the design control mechanism, then you’ll more easily avoid consequent DMR nonconformities and regulatory citations.

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