When the U.S. Food and Drug Administration (FDA) issued The Guidance on Test Method Validation, they failed to address the validation of measurement systems – but 21 CFR Part 820 requires measurement system analysis (MSA). To compensate for the lack of agency guidance and still meet regulatory requirements, the medical device industry turned to Gauge Repeatability & Reproducibility (Gauge R&R) studies, but the FDA is making it clear these studies are not a suitable tool for validation. Now what? Read the full article written by Coda Corp USA.
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