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

This article was originally published in The Gray Sheet

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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FDA Should Reassess Hacking Risk In Medical Devices, GAO Says

Tighter standards are needed to guard against wireless attacks of implantable or body-worn medical devices, but the attack risk should be weighed against potential adverse effects that may arise from security measures meant to address them, according to the Government Accountability Office.

Regulatory News In Brief

Regulatory news updates form the Hill, industry and FDA.

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