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Percentage of PMA, de novo and HDE decisions that includes a public summary of available and relevant patient perspective data considered

Dictionary: CDRH 2016-2017 Strategic Priority: Partner with Patients

Goal: Increase Use and Transparency of Patient Input as Evidence in Our Decision Making

FY 17 Accomplishment: All, 100% of PMAs, de novo, and HDEs pre-market decisions made by CDRH now include a public summary of available and relevant patient perspective data.

FY 17 Target: By September 30, 2017, 100% of PMA, de novo and HDE decisions will include a public summary of available and relevant patient perspective data considered.

FY 16 Accomplishment: In FY 2016, 65% of PMAs, de novo, and HDEs included a public summary of available patient perspective data.

FY 16 Target: By September 30, 2016, 50% of PMA, de novo and HDE decisions will include a public summary of available and relevant patient perspective data considered.

Information is current as of December 31, 2017.

Fiscal Year - 2016 to 2017

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TimeTargetPercentage
FY20165065
FY2017100100

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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