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New Massachusetts Senator Ed Markey Targeted ‘Defective Devices’ As House Member

This article was originally published in The Pink Sheet Daily

Executive Summary

Democrat Ed Markey was elected to the Senate in a Massachusetts special election June 25. In the House, he was a strong supporter of pediatric device development but also a vocal critic of industry and FDA’s device safety oversight. In particular, he has pushed for reforms to the 510(k) system that could limit companies’ use of predicate devices in 510(k) submissions.

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