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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.
| Goal | Tier | Review Time | Performance Level FY 2008 – FY 2012 Submissions |
|---|---|---|---|
| Issue a decision for 510(k)s | 1 | 90 days | 90% on time |
| 2 | 150 days | 98% 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
| Type | FY 05 | FY 06 | FY 07 | FY 08 | FY 09 |
|---|---|---|---|---|---|
| Submissions | 3,713 | 3,913 | 3,714 | 3,901* | 4,153 |
| MDUFA Cohort Submissions | 3,401 | 3,503 | 3,238 | 3,337 | 3,908 |
* 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.
| Goal | Tier | Performance Goals | Fiscal Year | Cohort Closed | Received | Pending Within Goal | Overdue | On Time | Percent On Time |
|---|---|---|---|---|---|---|---|---|---|
| Issue a decision for 510(k)s | 1 | Issue 90% within 90 days | 2008 | N | 3,337 | 46 | 210 | 3,081 | 94% |
| 2009 | N | 3,908 | 1,700 | 158 | 2,050 | 93% | |||
| 2 | Issue 98% within 150 days | 2008 | N | 3,337 | 60 | 51 | 3,226 | 98% | |
| 2009 | N | 3,908 | 1,754 | 18 | 2,136 | 99% |
[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
