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Unpacking Averages: The Seasonality of FDA 510(k) Decision-Making and the Impact of Michigan Playing for a National Championship

January 4, 2024

Frequently, I am asked by clients to predict how long it will take for FDA to review and clear a 510(k). At a high level, I observe that on average clearance can take 160 days according to the data. Then, beyond that, I observe that review times are highly variable among differing product codes, and the very first Unpacking Averages post I wrote in October 2021 provided a graphic to show just how much variation there was depending on the technology….
By: Epstein Becker & Green

Unpacking Averages: The Seasonality of FDA 510(k) Decision-Making and the Impact of Michigan Playing for a National Championship

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