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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Regulatory news updates form the Hill, industry and FDA.

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Sen. Markey Applauds CDRH Database Improvements

The Democratic senator from Massachusetts, highly critical of the potential for a device to be FDA-cleared with a predicate that has been recalled for safety issues, says he supports recent changes made by FDA’s device center to its recalls, 510(k) and PMA databases.

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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