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Postmarket Device Surveillance Reforms Raised At Califf Confirmation Hearing

Robert Califf responded to questions about improving postmarket device surveillance during his Nov. 17 confirmation hearing, including from HELP Committee Ranking Member Patty Murray, D-Wash., who raised the issue in relation to tainted duodenscopes that led to the deaths of several people in her state. Califf also addressed questions on lab-developed test oversight and charges that FDA overuses guidance documents.

Several senators pressed FDA commissioner nominee Robert Califf about what could be done to improve postmarket device surveillance during his Nov. 17 confirmation hearing in the Senate Health, Education, Labor and Pensions Committee. And Califf, currently a deputy commissioner at FDA, emphasized the need for funding from Congress to expand the Sentinel surveillance system to track device safety.

HELP Committee ranking member Patty Murray, D-Wash., raised the issue during the hearing particularly in relation to contamination incidents with duodenoscopes used in endoscopic retrograde cholangiopancreatographys (ERCP) procedures in Washington...

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