Utah Medical Products Inc. and the FDA: Regulatory Dogma versus Flexible Interpretation

Abstract

This paper reviews the regulatory compliance background and the 2005 court case between the Food and Drug Administration (FDA) and Utah Medical Products Incorporated which supported the company's and not the Agency's interpretation of 21 Code of Federal Regulations (CFR) Part 820, the Quality System Regulations (QSR). This is the first time that the Agency has lost such a court case; the key issues in the case are presented and discussed. The judgement also shows the value of re-reading the regulations to interpret what is actually required rather than custom and practice. Copyright © 2006 John Wiley & Sons, Ltd.