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U.S. Department of Health and Human Services

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Number of electronic patient records (from national and international registries claims data and EHRs) with device identification that CDRH gained access to

Dictionary: CDRH 2016-2017 Strategic Priority: Establish a National Evaluation System for Medical Devices

Goal: Increase Access to Real-World Evidence to Support regulatory Decision Making

2017 Accomplisment: Gained acccess to more than 103 million electronic patient records (from national and international clinical registries, claims data, and EHRs) with device identification using a variety of mechanisms, such as cooperative agreements and access through regulatory process.

2017 Target: By December 31, 2017, gain access to 100 million electronic patient records (from national and international clinical registries, claims data, and EHRs) with device identification.

2016 Accomplishment: Gained access to more than 28 million electronic patient records (from national and international clinical registries, claims data, and EHRs) with device identification using a variety of mechanisms, such as cooperative agreements and access through regulatory process.

2016 Target: By December 31, 2016, gain access to 25 million electronic patient records (from national and international clinical registries, claims data, and EHRs) with device identification.

Information is current as of December 31, 2017.

Fiscal Year - 2016 to 2017

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TimeTargetNumber (in millions)
20162528.6
2017100103

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

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