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CDRH postmarket reengineering team

This article was originally published in The Gray Sheet

Executive Summary

Thirteen-member group is conducting weekly meetings to collect feedback on postmarket surveillance and discuss potential initiatives. Brian Harvey, CDRH Office of Device Evaluation, co-heads the team with Tom Gross from the Office of Surveillance and Biometrics. After presenting project ideas to outgoing center Director Bruce Burlington Feb. 19, the team will split into subgroups to design pilot programs in areas such as MDR reporting, device tracking, surveillance and Sentinel reporting. The pilots should be in place by early summer

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