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U.S. Department of Health and Human Services

Medical Devices

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January 28, 2009 FDA MDUFMA Performance Report - Quarterly Update on Medical Device Performance Goals - CDRH Performance Data

 

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Actions through December 31, 2008

Data on FY 2003 – FY 2007 Cohorts
PMAs and Panel-Track Supplements
CDRH Actions through December 31, 2008
Workload (Applications Filed to Date)
  FY 2003 FY 2004 FY 2005 FY 2006 FY 2007
PMAs 40 39 41 37 33
Panel-Track Supplements 7 8 11 16 4
Total Workload 47 47 52 53 37

 

FDA Decisions
  FY 2003 FY 2004 FY 2005 FY 2006 FY 2007
FDA Decisions 47 47 51 50 32
Goal – Percent within 320 days
- - - 80% 90%
Percent of decisions within 320 days 91.5% 91.5% 86.3% 80.0% 96.9%
Applications without a decision 0 0 1 3 5
Cohort status Complete Complete Open Open Open
Goal – Percent within 180 days - - - - 50%
Percent of decisions within 180 days 44.7% 36.2% 31.4% 36.0% 62.5%

PMA and Panel Track PMA Supplements
Percent of CDRH Decisions Meeting 320-day MDUFMA Goal

Graph, PMA and Panel-Track PMA Supplements. Fiscal Year versus Percent of CDRH Decisions Meeting 320-day MDUFMA Goal. Percent of decisions within 320 days, for FY 2003, 91.5%, for FY 2004, 91.5%, for for FY 2005, 86.3%, for FY 2006, 80%, for FY 2007, 96.9%.

  • Progress to date indicates CDRH will likely meet the goals for FY 2006 and FY 2007.
  • The FY 2003 and FY 2004 cohorts are complete. All other cohorts remain open.
Expedited PMAs
CDRH Actions through December 31, 2008
Workload (Applications Filed to Date)
  FY 2003 FY 2004 FY 2005 FY 2006 FY 2007
Expedited PMAs 3 14 6 2 2
FDA Decisions
  FY 2003 FY 2004 FY 2005 FY 2006 FY 2007
FDA Decisions 3 13 6 2 1
Goal – Percent within 300 days
- - 70% 80% 90%
Percent of decisions within 300 days 100.0% 92.3% 83.3% 50.0% 0
Applications without a decision 0 1 0 0 1
Cohort Status Complete Open Complete Open Open

Expedited PMAs
Percent of CDRH Decisions meeting MDUFMA Goal

Graph, Expedited PMAs. Fiscal Year versus Percent of CDRH Decisions Meeting 300-day MDUFMA Goal. Percent of decisions within 300 days, for FY 2003, 100%, for FY 2004, 92.3%, for FY 2005, 83.3%, for FY 2006, 50%, for FY 2007, 0%.

  • FY 2003 and FY 2005 cohorts are complete; all other cohorts remain open.
  • Because of the small number of Expedited PMAs, a single action may signficantly affect performance measures.
180-day PMA Supplements
CDRH Actions through December 31, 2008
Workload
  FY 2003 FY 2004 FY 2005 FY 2006 FY 2007
180-day PMA Supplements 201 103 99 134 140

 

FDA Decisions
  FY 2003 FY 2004 FY 2005 FY 2006 FY 2007
FDA Decisions 201 103 99 133 139
Goal – Percent within 180 days
-
- 80% 80% 90%
Percent of decisions within 180 days 94.0% 95.1% 94.9% 96.2% 92.1%
Applications without a decision 0 0 0 1 1
Cohort Status Complete Complete Complete Open Open

180-day PMA Supplements
Percent of CDRH Decisions Meeting MDUFMA Goal

Graph, 180-Day PMA Supplements Fiscal Year versus Percent of CDRH Decisions Meeting 180-day MDUFMA Goal. Percent of decisions within 180 days, for FY 2003, 94%, for FY 2004, 95.1%, for FY 2005, 94.9%, for FY 2006, 96.2%, for FY 2007, 92.1%

  • FY 2003, FY 2004, and FY 2005 cohorts are complete.
510(k) Premarket Notifications
CDRH Actions through December 31, 2008
Workload
  FY 2003 FY 2004 FY 2005 FY 2006 FY 2007
Received 4,225 3,632 3,650 3,853 3,656
MDUFMA Cohort¹ 3,741 3,309 3,344 3,446 3,168

¹ The MDUFMA Cohort excludes 510(k)s that were closed for any reason other than an SE or NSE decision (e.g., when FDA finds that a 510(k) was not required). The number of 510(k)s in the MDUMFA Cohort is subject to change until the cohort is complete.

FDA Decisions (SE and NSE Determinations)
  FY 2003 FY 2004 FY 2005 FY 2006 FY 2007
FDA Decisions (SE and NSE) 3,741 3,309 3,344 3,446 3,168
Goal – Percent within 90 days
- - 75% 75% 80%
Percent of decisions within 90 days 75.7% 83.6% 91.0% 91.3% 91.2%
Remaining applications 0 0 1 4 26
Cohort Status Complete Complete Open Open Open

510(k) Premarket Notifications
Percent of CDRH Decisions Meeting MDFUMA Goal

  • Graph, 510(k) Premarket Notifications. Fiscal Year versus Percent of CDRH Decisions Meeting MDUFMA Goal. Percent of decisions within 90 days, for FY 2003, 75.7%, for FY 2004, 83.6%, for FY 2005, 91%, for FY 2006, 91.3%, for FY 2007, 91.2%.
Data on FY 2008 – FY 2012 Cohorts
PMAs and Panel-track Supplements
  FY 2008 FY 2009 FY 2010 FY 2011 FY 2012
Workload (Filed to Date) 33 4 - - -
Total FDA Decisions 8 0 - - -
Percent within Tier 1 goal (180 days) 100.0% - - - -
Tier 1 goal — Percent within 180 days 60% 60% 60% 60% 60%
Percent within Tier 2 goal (295 days) 100.0% 0.0% - - -
Tier 2 goal — Percent within 295 days 90% 90% 90% 90% 90%
Cohort Status Open Open - - -

PMAs and Panel-track PMA Supplements
Percent of CDRH Decisions Meeting FY 2008 - FY 2012 Goals

Graph, PMA and Panel-Track PMA Supplements. Percent of CDRH Decisions Meeting FY 2008-2012 Goals Percent within Tier 1 goal (180 days), For FY 2008, 100%, for FY 2009, 0, for FY 2010, 0, for FY 2011, 0, for FY 2012, 0. Percent within Tier 2 goal (180 days), For FY 2008, 100%, for FY 2009, 0, for FY 2010, 0, for FY 2011, 0, for FY 2012, 0.

Expedited PMAs and Expedited Panel-track Supplements
  FY 2008 FY 2009 FY 2010 FY 2011 FY 2012
Workload (Filed to Date) 4 0 - - -
Total FDA Decisions 0 0 - - -
Percent within Tier 1 goal (180 days) - - - - -
Tier 1 goal — Percent within 180 days 50% 50% 50% 50% 50%
Percent within Tier 2 goal (280 days) - - - - -
Tier 2 goal — Percent within 280 days 90% 90% 90% 90% 90%
Cohort Status Open Open - - -

Expedited PMAs and Expedited Panel-track Supps
Percent of CDRH Decisions Meeting FY 2008 - FY 2012 Goals

Graph, Expedited PMAs and Expedited Panel-Track PMA Supplements. Percent of CDRH Decisions Meeting FY 2008-2012 Goals. Percent within Tier 1 goal (180 days), For FY 2008, 0, for FY 2009, 0, for FY 2010, 0, for FY 2011, 0, for FY 2012, 0. Percent within Tier 2 goal (280 days), For FY 2008, 0, for FY 2009, 0, for FY 2010, 0, for FY 2011, 0, for FY 2012, 0.

PMA Modules
  FY 2008 FY 2009 FY 2010 FY 2011 FY 2012
Workload (Filed to Date) 43 15 - - -
MDUFMA Cohort 44 15 - - -
Total FDA Decisions 44 1 - - -
Percent within Tier 1 goal (90 days) 52.3% 100.0% - - -
Tier 1 goal — Percent within 90 days 75% 75% 75% 75% 75%
Percent within Tier 2 goal (120 days) 90.9% 100.0% - - -
Tier 2 goal — Percent within 120 days 90% 90% 90% 90% 90%
Cohort Status Open Open - - -

PMA Modules
Percent of CDRH Decisions Meeting FY 2008 - FY 2012 Goals

Graph, PMA Modules. Percent of CDRH Decisions Meeting FY 2008-2012 Goals. Percent within Tier 1 goal (90 days), For FY 2008, 52.3%, for FY 2009, 100%, for FY 2010, 0, for FY 2011, 0, for FY 2012, 0. Percent within Tier 2 goal (120 days), For FY 2008, 90.9%, for FY 2009, 100%, for FY 2010, 0, for FY 2011, 0, for FY 2012, 0.

180-day PMA Supplements
  FY 2008 FY 2009 FY 2010 FY 2011 FY 2012
Workload (Filed to Date) 168 33 - - -
Total FDA Decisions 120 3 - - -
Percent within Tier 1 goal (180 days) 96.7% 100.0% - - -
Tier 1 goal — Percent within 180 days 85% 85% 85% 85% 85%
Percent within Tier 2 goal (210 days) 99.2% 100.0% - - -
Tier 2 goal — Percent within 210 days 95% 95% 95% 95% 95%
Cohort Status Open Open - - -

180-Day PMA Supplements
Percent of CDRH Decisions Meeting FY 2008 - FY 2012 Goals

Graph, 180-Day PMA Supplements. Percent of CDRH Decisions Meeting FY 2008-2012 Goals. Percent within Tier 1 goal (180 days), For FY 2008, 96.7%, for FY 2009, 100%, for FY 2010, 0, for FY 2011, 0, for FY 2012, 0. Percent within Tier 2 goal (210 days), For FY 2008, 99.2%, for FY 2009, 100%, for FY 2010, 0, for FY 2011, 0, for FY 2012, 0.

Real-time PMA Supplements
  FY 2008 FY 2009 FY 2010 FY 2011 FY 2012
Workload (Filed to Date) 248 80 - - -
Total FDA Decisions 235 44 - - -
Percent within Tier 1 goal (60 days) 96.6% 100.0% - - -
Tier 1 goal — Percent within 60 days 80% 80% 80% 80% 80%
Percent within Tier 2 goal (90 days) 99.6% 100.0% - - -
Tier 2 goal — Percent within 90 days 90% 90% 90% 90% 90%
Cohort Status Open Open - - -

Real-time PMA Supplements
Percent of CDRH Decisions Meeting FY 2008 - FY 2012 Goals

Graph, Real-time PMA Supplements. Percent of CDRH Decisions Meeting FY 2008-2012 Goals. Percent within Tier 1 goal (60 days), For FY 2008, 96.6%, for FY 2009, 100%, for FY 2010, 0, for FY 2011, 0, for FY 2012, 0. Percent within Tier 2 goal (90 days), For FY 2008, 99.6%, for FY 2009, 100%, for FY 2010, 0, for FY 2011, 0, for FY 2012, 0.

510(k)s
  FY 2008 FY 2009 FY 2010 FY 2011 FY 2012
Workload (Received to Date) 3,851 995 - - -
MDUFMA Cohort 2,820 159 - - -
Total FDA Decisions 2,830 0 - - -
Percent within Tier 1 goal (90 days) 96.4% - - - -
Tier 1 goal — Percent within 90 days 90% 90% 90% 90% 90%
Percent within Tier 2 goal (150 days) 99.6% - - - -
Tier 2 goal — Percent within 150 days 98% 98% 98% 98% 98%
Cohort Status Open Open - - -

510(k) Premarket Notification
Percent of CDRH Decisions Meeting FY 2008 - FY 2012 Goals

Graph, Modules. Percent of CDRH Decisions Meeting FY 2008-2012 Goals. Percent within Tier 1 goal (90 days), For FY 2008, 96.4%, for FY 2009, 100%, for FY 2010, 0, for FY 2011, 0, for FY 2012, 0. Percent within Tier 2 goal (150 days), For FY 2008, 99.6%, for FY 2009, 0%, for FY 2010, 0, for FY 2011, 0, for FY 2012, 0.

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