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Utah Medical Fallout
I saw an article in the April 2008 issue of Medical Device and Diagnostic Industry about United States of America vs. Utah Medical Products, Inc. which is relevant to all medical device companies. In case you are not familiar with the details of the decision, Utah Medical had a series of poor regulatory inspections starting in 2001. You can see all of their FD483’s and EIRs at http://www.fda.gov/ora/frequent. In response, the FDA filed charges against them for failure to comply with the QSR, and the decision was made in October 2005 in Utah Medical’s favor.

The essential element of the decision is that “Many roads lead to Rome” which means:
  • The Quality System Regulation (21CFR820) is the law and specifies what must be accomplished.
  • Guidance documents, Global Harmonization Task Force, and industry standards are not the law because they describe how compliance tasks are to be done.
Because the content of the 483s were failures in the quality system derived from Guidance documents and industry standards, the judge ruled in Utah Medical’s favor.

This should be the end of the story, but unfortunately, it is not. As mentioned in the article, FDA is ignoring the ruling and shall continue as if nothing happened. What this means to you is that if you want to avoid 483s and don’t want to go to court to prove your position, you should try to follow these recommendations:
  1. Conform to Guidance where possible. At least two Guidance documents that would apply to you would be General Principles of Software Validation and Guideline of General Principles of Process Validation. Links to both these documents are located on my web site under Downloads.
  2. For all those elements where you do not follow the guidance document, thoroughly document those deviations from guidelines. For example, if you do not perform Worse-case studies during a PQ, you should document that rationale.
  3. Be sure to remove Guidance documents from your requirements documents. Although it is not required to comply with specific Guidance documents, if it clearly states in a protocol, procedure, or work instruction that “We shall comply with the General Principles of Process Validation,” then you can be cited. Instead, itemize the requirements individually in your documentation.

If you would rather talk about this in person, give me a toll-free call at 888-900-9813.