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510(k) Premarket Notifications

FY 2009 MDUFA Performance Report Table of Contents

Goals

The table below summarizes the Tier 1 and Tier 2 performance goals for 510(k) submissions. Performance goals are applied to the MDUFA cohort submissions.

GoalTierReview TimePerformance Level
FY 2008 – FY 2012 Submissions
Issue a decision for 510(k)s190 days90% on time
2150 days98% on time

 

 

Workload

The number of 510(k) submissions as well as the MDUFA cohort portion of 510(k) submissions increased in FY 2009 and reached 5-year highs (see corresponding graph and table). The MDUFA cohort portion of 510(k) submissions represented 94 of every 100 submissions in FY 2009. [9]

510(k) Premarket Notifications MDUFA FY 2009

510(k) Premarket Notifications

TypeFY 05FY 06FY 07FY 08FY 09
Submissions3,7133,9133,7143,901*4,153
MDUFA Cohort Submissions3,4013,5033,2383,3373,908

* FY 2008 number was updated to reflect a correction to the FY 2008 MDUFA Performance Report.

Performance

As of September 30, 2009, performance data was available for virtually all (3,291 of 3,337) 510(k) FY 2008 submissions and over half (2,208 of 3,908) of FY 2009 submissions.

  • FDA met the Tier 1 review-time goal for 3,081 of 3,291 submissions in FY 2008 and 2,050 of 2,208 submissions in FY 2009. With submissions pending within goal, FDA will exceed the Tier 1 performance goal for FY 2008 and has the potential to exceed the Tier 1 performance goal for FY 2009.
  • FDA met the Tier 2 review-time goal for 3,226 of 3,277 submissions in FY 2008 and 2,136 of 2,154 submissions in FY 2009. With submissions pending within goal, FDA has the potential to exceed the Tier 2 performance goal for FY 2008 and FY 2009.
     
GoalTier Performance
Goals
Fiscal YearCohort ClosedReceivedPending
Within Goal
OverdueOn TimePercent
On Time
Issue a decision
for 510(k)s
1Issue 90% within
90 days
2008N3,337462103,08194%
2009N3,9081,7001582,05093%
2Issue 98% within
150 days
2008N3,33760513,22698%
2009N3,9081,754182,13699%

 [9] The MDUFA cohort for 510(k)s excludes submissions that were closed for any reason other than an SE or NSE decision [for example, when FDA finds that a 510(k) was not required].

Next page: Report on Additional MDUFA II Performance Commitments