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Percent of death Medical Device Reports (MDRs) reviewed within 5 business days during the month
Dictionary: OSB strives to review medical device adverse events resulting in death within 5 business days of receiving the submission. Timely review of death MDRs can minimize widespread failure of the device, thereby limiting the loss of life due to similar events as the one submitted.
Information is current as of December 31, 2012
Fiscal Year - 2011
| Time | Target | Percent |
|---|---|---|
| Oct 2010 | 90 | 97 |
| Nov 2010 | 90 | 97 |
| Dec 2010 | 90 | 99 |
| Jan 2011 | 90 | 99 |
| Feb 2011 | 90 | 99 |
| Mar 2011 | 90 | 99 |
| Apr 2011 | 90 | 99 |
| May 2011 | 90 | 100 |
| Jun 2011 | 90 | 99 |
| Jul 2011 | 90 | 99 |
| Aug 2011 | 90 | 100 |
| Sep 2011 | 90 | 99 |
FY 2011 Overall: 99%
Number of death MDRs reviewed within 5 business days during the month
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 411 |
| Nov 2010 | N/A | 445 |
| Dec 2010 | N/A | 629 |
| Jan 2011 | N/A | 515 |
| Feb 2011 | N/A | 687 |
| Mar 2011 | N/A | 2,177 |
| Apr 2011 | N/A | 942 |
| May 2011 | N/A | 935 |
| Jun 2011 | N/A | 622 |
| Jul 2011 | N/A | 535 |
| Aug 2011 | N/A | 697 |
| Sep 2011 | N/A | 680 |
FY 2011 Total: 9,275
Total number of death MDRs reviewed during the month
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 423 |
| Nov 2010 | N/A | 458 |
| Dec 2010 | N/A | 637 |
| Jan 2011 | N/A | 521 |
| Feb 2011 | N/A | 691 |
| Mar 2011 | N/A | 2,200 |
| Apr 2011 | N/A | 950 |
| May 2011 | N/A | 936 |
| Jun 2011 | N/A | 626 |
| Jul 2011 | N/A | 543 |
| Aug 2011 | N/A | 698 |
| Sep 2011 | N/A | 685 |
FY 2011 Total: 9,368
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.
