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Congress Enters Final Stages On FDA Reform Bill

This article was originally published in The Gray Sheet

Executive Summary

Legislative leaders say they remain on track to send FDA user fee reauthorization and reform legislation for the president’s signature by the end of June following House passage of bill.

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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.

FDA Issues Work Plan For Independent Assessment Of Pre-market Review Process

The assessment, called for by industry during the device user fee reauthorization, will be conducted by an independent consulting firm. The goal is to identify efficiencies in the device review process.

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