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Percentage of times a decision is issued for a 510(k) within 90 days
Dictionary: A 510(k) is a premarket notification made to FDA which contains information that demonstrates that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to Premarket Approval (PMA). This measure will allow OBRR to determine its performance in issuing decisions within established timeframes.
Information is current as of September 30, 2012
Fiscal Year - 2010
| Time | Target | Percent |
|---|---|---|
| Oct 2009 | 90 | 100 |
| Nov 2009 | 90 | 100 |
| Dec 2009 | 90 | 100 |
| Jan 2010 | 90 | 100 |
| Feb 2010 | 90 | 100 |
| Mar 2010 | 90 | 100 |
| Apr 2010 | 90 | 100 |
| May 2010 | 90 | 100 |
| Jun 2010 | 90 | 100 |
| Jul 2010 | 90 | 100 |
| Aug 2010 | 90 | 83 |
| Sep 2010 | 90 | 100 |
FY 2010 Overall: 98%
Number of 510(k) premarket notifications with final action issued during the month, for which final action was issued within the statutory 90 day FDA review time
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 2 |
| Nov 2009 | N/A | 4 |
| Dec 2009 | N/A | 3 |
| Jan 2010 | N/A | 5 |
| Feb 2010 | N/A | 3 |
| Mar 2010 | N/A | 2 |
| Apr 2010 | N/A | 3 |
| May 2010 | N/A | 4 |
| Jun 2010 | N/A | 6 |
| Jul 2010 | N/A | 7 |
| Aug 2010 | N/A | 5 |
| Sep 2010 | N/A | 1 |
FY 2010 Total: 45
Number of 510(k) premarket notifications with final action issued during the month
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 2 |
| Nov 2009 | N/A | 4 |
| Dec 2009 | N/A | 3 |
| Jan 2010 | N/A | 5 |
| Feb 2010 | N/A | 3 |
| Mar 2010 | N/A | 2 |
| Apr 2010 | N/A | 3 |
| May 2010 | N/A | 4 |
| Jun 2010 | N/A | 6 |
| Jul 2010 | N/A | 7 |
| Aug 2010 | N/A | 6 |
| Sep 2010 | N/A | 1 |
FY 2010 Total: 46
Glossary
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.
