In what is possibly the first of many such cases, Federal Judge Bruce S. Jenkins overturned the FDA’s Quality System Regulation (QSR) allegations against Utah Medical Products, Inc. Essentially, the case hinged on functional definitions of the word “validation.”
At issue was a disagreement over how the company sought to meet QSR requirements in the areas of adequately validating its manufacturing process, validating its software and uniform complaint
handling process. In August 2004 the FDA sought to shut down the operation of Utah Medical’s 160-person facility in Midvale, Utah.
“The common mission of the manufacturer and the regulating agency is a safe product and the adoption of manufacturing processes which ensure safety. Product safety is not an issue in this case,” Judge Jenkins wrote in his opinion. “Processes and procedures are. ‘Validation’ is the key word, and has often been noted, ‘many roads lead to Rome.'”
Jenkins wrote that the FDA’s case, which he characterized as “extended and in some instances ‘nitpicking,'” arose “in part because of the general nature of the regulations themselves, which have the virtue of generality and the vice of imprecision. This endemic problem is perhaps augmented by decision-makers who themselves rely too much on inspectors’ reports without taking a fresh look themselves at ongoing changes made by Utah Medical in response to questions raised.”
Probably the most important aspect of the case is highlited by attorney Larry Pilot:
Its courage in defending itself against meritless claims by the FDA should inspire all medical device and pharmaceutical companies to question the performance and the sincerity of the FDA as it evaluates the very meaning of compliance. This precedent setting opinion is a major accomplishment for the entire FDA regulated industry.