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U.S. Department of Health and Human Services

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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 - 2013

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TimeTargetPercent
Oct 2012N/A94
Nov 2012N/A98
Dec 2012N/A93
Jan 2013N/ATBD
Feb 2013N/ATBD
Mar 2013N/ATBD
Apr 2013N/ATBD
May 2013N/ATBD
Jun 2013N/ATBD
Jul 2013N/ATBD
Aug 2013N/ATBD
Sep 2013N/ATBD

FY 2013 YTD: 95%

Number of death MDRs reviewed within 5 business days during the month

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A510
Nov 2012N/A375
Dec 2012N/A413
Jan 2013N/ATBD
Feb 2013N/ATBD
Mar 2013N/ATBD
Apr 2013N/ATBD
May 2013N/ATBD
Jun 2013N/ATBD
Jul 2013N/ATBD
Aug 2013N/ATBD
Sep 2013N/ATBD

FY 2013 YTD: 1,298

Total number of death MDRs reviewed during the month

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A542
Nov 2012N/A381
Dec 2012N/A442
Jan 2013N/ATBD
Feb 2013N/ATBD
Mar 2013N/ATBD
Apr 2013N/ATBD
May 2013N/ATBD
Jun 2013N/ATBD
Jul 2013N/ATBD
Aug 2013N/ATBD
Sep 2013N/ATBD

FY 2013 YTD: 1,365

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.