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Home » Third-party reviews of 510(k) applications trending nearly flat since 2018
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Third-party reviews of 510(k) applications trending nearly flat since 2018

April 12, 2022
By Mark McCarty
The FDA program for third-party review of 510(k) applications was designed to take some of the load off the agency’s review staff and thus allow the agency to focus on more complex filings, but recent data suggest that the program has had only a modest effect on the FDA’s workload. The number of third-party reviews for the current and two previous fiscal years only modestly exceed the numbers from fiscal years 2018 and 2019, a conspicuous trend given the distractions at the FDA’s device arising from its work to manage the COVID-19 pandemic.
BioWorld MedTech Regulatory U.S. 510(k) CDRH FDA

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