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U.S. Department of Health and Human Services

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Percent of Post-Approval Study (PAS) decision letters completed within established time frames during the month

Dictionary: The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. This program is critical for identifying side effects that were not identifiable during the premarket testing phase. This measure evaluates CDRH’s timeliness in issuing decision letters for various stages of the post-approval commitments, including post-approval protocols and reviews of interim and final study reports.

Information is current as of September 30, 2013

Fiscal Year - 2013

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TimeTargetPercent
Oct 20129098
Nov 20129093
Dec 20129091
Jan 20139098
Feb 20139079
Mar 20139089
Apr 20139092
May 20139098
Jun 20139089
Jul 20139080
Aug 20139063
Sep 20139056

FY 2013 Overall: 85%

Number of PAS decision letters completed within established time frames during the month

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A48
Nov 2012N/A50
Dec 2012N/A48
Jan 2013N/A43
Feb 2013N/A48
Mar 2013N/A40
Apr 2013N/A46
May 2013N/A44
Jun 2013N/A51
Jul 2013N/A39
Aug 2013N/A32
Sep 2013N/A31

FY 2013 Total: 520

Total number of PAS decision letters completed during the month

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A49
Nov 2012N/A54
Dec 2012N/A53
Jan 2013N/A44
Feb 2013N/A61
Mar 2013N/A45
Apr 2013N/A50
May 2013N/A45
Jun 2013N/A57
Jul 2013N/A49
Aug 2013N/A51
Sep 2013N/A55

FY 2013 Total: 613

Glossary

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.