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Sen. Murray Prods FDA To Clarify 510(k) Modification Policies In Superbug Bill

This article was originally published in The Gray Sheet

Executive Summary

Following up on recommendations made in her January report on duodenoscope contamination, Senate HELP Ranking Member Patty Murray, D-Wash., introduced a bill pressing FDA to accelerate its work to clarify when 510(k)s are needed for device modifications and to solidify the agency's authority to deny submissions if the sponsor fails to provide validated reprocessing data.


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