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BioWorld - Friday, March 29, 2024
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» FDA, Health Canada unfurl harmonized premarket submission mechanism
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FDA, Health Canada unfurl harmonized premarket submission mechanism
Jan. 12, 2023
By
Mark McCarty
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The U.S. FDA and Health Canada announced that they will roll out a pilot program that allows a medical device manufacturer to submit a medical device application to both agencies simultaneously for class II and class III medical devices.
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