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Percentage increase of the number of premarket and postmarket regulatory decisions that leverage real-world evidence (compared to FY2015 baseline)

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

Goal: Increase the Use of Real-World Evidence to Support Regulatory Decision Making

2017 Accomplishment: The number of premarket and postmarket regulatory decisions that used real-world evidence increased by 193% in 2017 (compared to FY2015 baseline).

2017 Target: By December 31, 2017, increase by 100% the number of premarket and postmarket regulatory decisions that leverage real-world evidence (compared to FY2015 baseline).

2016 Accomplishment: The number of premarket and postmarket regulatory decisions that used real-world evidence increased by 85% in 2016 (compared to FY2015 baseline).

2016 Target: By December 31, 2016, increase by 40% the number of premarket and postmarket regulatory decisions that leverage real-world evidence (compared to FY2015 baseline).

Information is current as of December 31, 2017.

Fiscal Year - 2016 to 2017

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TimeTargetPercentage
20164085
2017100193

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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