510(k)s

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510(k)s. Percent of 510(k)s With Additional Information (AI) Request on 1 st FDA Review Cycle. Average Time to Decision: 510(k)s* (Receipt Cohorts as of June 30, 2012). *SE and NSE decisions only; times may not add to total due to rounding - PowerPoint PPT Presentation

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Page 1: 510(k)s

510(k)s

Page 2: 510(k)s

2

Percent of 510(k)s With Additional Information (AI) Request on 1st FDA Review Cycle

Page 3: 510(k)s

3

Average Time to Decision: 510(k)s*(Receipt Cohorts as of June 30, 2012)

*SE and NSE decisions only; times may not add to total due to rounding**Cohorts still open; FY 2011 cohort is only 95% closed and average times will increase

Page 4: 510(k)s

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Average Time to Decision: 510(k)s*- Comparison of Receipt Cohorts When 95% Closed -

*SE and NSE decisions only; times may not add to total due to rounding

Page 5: 510(k)s

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510(k)s Pending* at End of Year

*Under review or on hold**FY 2012 is as of June 30, 2012

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Percent of 510(k)s Determined to be Substantially Equivalent (SE)

Page 7: 510(k)s

PMAs

Page 8: 510(k)s

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Percent of PMAs With Major Deficiency Letter (MAJR) on 1st FDA Review Cycle*

*Includes all filed original PMAs (1st cycle completed for all cohorts)

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Average Time to MDUFA Decision: PMAs*(Filed Cohorts as of July 16, 2012)

*Includes all filed original PMAs; times may not add to total due to rounding**Cohorts still open, average times will increase; percent of cohort with MDUFA decision: FY05 = 98% (46/47); FY10 = 98% (42/43); FY11 = 81% (35/43)

Page 10: 510(k)s

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Average Time to MDUFA Decision: PMAs*- Comparison of Filed Cohorts When Approx. 98% Closed** -

*Includes all filed original PMAs; times may not add to total due to rounding**Proportion of cohort closed (MDUFA decision): FY07 = 34/35; FY08 = 29/30; FY09 = 31/32; FY10 = 42/43; FY11 = (not yet 98%)

Page 11: 510(k)s

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Average Time to MDUFA Decision: PMAs*- Comparison of Filed Cohorts When Approx. 81% Closed** -

*Includes all filed original PMAs; times may not add to total due to rounding**Proportion of cohort closed (MDUFA decision): FY07 = 28/35; FY08 = 23/30; FY09 = 26/32; FY10 = 35/43; FY11 = 35/43

Page 12: 510(k)s

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PMAs Pending* at End of Year

*All original PMAs under review or on hold**FY 2012 is as of July 16, 2012

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Percent of PMAs Approved*

*Based on original PMAs that were accepted for filing

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