Quality Requirements and Standards
May 6th 2024 will forever be etched into the history of regulation. It's the date that the FDA issued its Final Rule on Laboratory-Developed Tests (LDTs). This is the introduction to this momentous, some might say monstrous, occurrence.
As Yogi Bera once said, "In theory, there is no difference between theory and practice - in practice, there is." So is it true with mu.
The biggest change in the Prague conference on quality may be a shifting of goalposts.
It's becoming something of a trend in Europe: lowering standards, postponing implementation of standards, and inventing new reasons why the rules don't apply.
Another year, another new model. Almost regularly as the planet circles the sun does a new model emerge in the literature. The latest is called "Precision QC." Have we been practicing "Imprecision QC" for the last 60 years? Do we need to recreate the QC wheel again?