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Physio-Control compliance status

This article was originally published in The Gray Sheet

Executive Summary

Redmond, Washington-based Lilly subsidiary found in compliance with good manufacturing practices and medical device reporting regulations following a recent FDA inspection. The firm still awaits FDA clearance of 510(k)s for changes made to its devices. The company has been barred from manufacturing or selling products in the U.S. since entering a consent decree with FDA in July 1992 ("The Gray Sheet" July 27, 1992, p. 1) and failed an initial reinspection in late 1992. Under the consent decree, the firm has to gain special FDA authorization to market its devices following the resolution of regulatory issues. Physio- Control says it will initially ask FDA to authorize sales of its Lifepak 10 external defibrillator and then will seek an okay for sales of the Lifepak 9 and Lifepak 300 products.



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