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LAERDAL SEEKS WITHDRAWAL OF WARNING LETTER ON CHANGES

This article was originally published in The Gray Sheet

Executive Summary

LAERDAL SEEKS WITHDRAWAL OF WARNING LETTER ON CHANGES to its Heartstart 3000 series of automatic external defibrillators in an Oct. 11 citizen's petition submitted to FDA. The firm maintains that premarket notification violations alleged in the agency's Sept. 19 letter have "no factual or legal basis" in that the modified AEDs do not raise new issues of safety and effectiveness. The company argues that the issues discussed in the warning letter "were resolved by and subsumed within the judgment rendered" by a U.S. District Court in May in litigation between FDA and Laerdal.
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