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As of January 31, 2023, there are 4840 open recommendations that still need to be addressed. 471 of these are priority recommendations, those that we believe warrant priority attention. Learn more about our priority designation on our Recommendations page.

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Antibiotic Resistance: Additional Federal Actions Needed to Better Determine Magnitude and Reduce Impact

1 Open Recommendations
Agency Recommendation Status
Office of the Commissioner The Commissioner of FDA should direct the Center for Devices and Radiological Health to conduct additional monitoring and evaluation of the status of FDA-authorized tests that rely on breakpoints, on a regular basis, to determine whether test manufacturers are updating breakpoints, seeking additional resources as needed. (Recommendation 6)
Open – Partially Addressed

The Department of Health and Human Services and the Food and Drug Administration concurred with this recommendation. FDA's Center for Devices and Radiological Health provided information regarding their initial effort to address this recommendation as of June 2021. FDA prepared and distributed a letter to manufacturers of tests relying on breakpoints encouraging the manufacturers to check the FDA website for updates and for guidance regarding when to submit an application to petition for changes to such tests. FDA stated this step represents a building block for monitoring and evaluating these

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