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Canada's Final User-Fee Schedule To Include Three Fee-Reduction Provisions

This article was originally published in The Gray Sheet

Executive Summary

Final user-fee regulations aimed at recouping the cost of implementing and maintaining Canada's revised medical device regulatory framework are tentatively scheduled for publication in June in the Canada Gazette Part II pending final approval by the Canadian Health Ministry and Treasury Board.

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PMA ABCs: Action definitions and procedures guidance will explain terms related to all PMA decisions listed under the performance goals of MDUFMA, ranging from "approval" and "approvable pending GMP" to "denial" and "abandonment," CDRH Premarket Approval Section Director Thinh Nguyen reports at the Regulatory Affairs Professionals Society medical device conference in San Francisco March 4. One of six PMA-related guidances under development, the document will provide criteria for decision letters and explain how certain actions affect FDA's review clock and performance goals...

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