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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 December 31, 2012

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

Fiscal Year - 2012

Time	Target	Number
Oct 2011	N/A	47
Nov 2011	N/A	51
Dec 2011	N/A	53
Jan 2012	N/A	49
Feb 2012	N/A	55
Mar 2012	N/A	50
Apr 2012	N/A	48
May 2012	N/A	54
Jun 2012	N/A	60
Jul 2012	N/A	49
Aug 2012	N/A	64
Sep 2012	N/A	33

FY 2012 Total: 613

Total number of PAS decision letters completed during the month

Fiscal Year - 2012

Time	Target	Number
Oct 2011	N/A	49
Nov 2011	N/A	52
Dec 2011	N/A	55
Jan 2012	N/A	51
Feb 2012	N/A	58
Mar 2012	N/A	50
Apr 2012	N/A	49
May 2012	N/A	56
Jun 2012	N/A	66
Jul 2012	N/A	49
Aug 2012	N/A	65
Sep 2012	N/A	37

FY 2012 Total: 637