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Medical device tracking

This article was originally published in The Gray Sheet

Executive Summary

Comments are due July 24 on an April 25 proposed rule implementing changes to the medical device tracking regulations as mandated by the FDA Modernization Act. The 1997 law allows patients with tracked devices to refuse permission to release identifying information for tracking purposes. The rule estimates that the cost to industry of maintaining tracking systems will increase from $40 mil. in 1999 to $71 mil. in 2006
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