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Markey Bill Would Bar 510(k) Clearances Of Devices With Recalled Predicates

This article was originally published in The Gray Sheet

Executive Summary

Sponsors say the bill “closes a significant loophole that currently puts patients at serious risk of debilitating injury by ensuring that devices do not mimic the mistakes made by other products.”

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

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.

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

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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