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U.S. Department of Health and Human Services

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Percent of Office of In Vitro Diagnostics and Radiological Health (OIR) 510(k) decisions meeting MDUFA goals during the month

Dictionary: The Medical Device User Fee Amendments (MDUFA II) require FDA to pursue a comprehensive set of device review performance goals, intended to significantly improve the timeliness and predictability of FDA’s review of new devices. MDUFA II performance goals are measured by receipt cohort. By using the decision cohort, this measure provides a different approach to monitoring MDUFA related 510(k) performance goals. The measure tracks the number of 510(k) decisions made during the month that were within 90 FDA days. A 510(k) is a premarket submission made to FDA to demonstrate 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 a Premarket Approval (PMA).

Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency (SE) claims. A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE through the 510(k) process. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate.

Information is current as of September 30, 2013

Fiscal Year - 2011

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Oct 20108579
Nov 20108585
Dec 20108580
Jan 20118595
Feb 20118587
Mar 20118575
Apr 20118588
May 20118587
Jun 20118585
Jul 20118588
Aug 20118588
Sep 20118587

FY 2011 Overall: 85%

Number of OIR 510(k) decisions made in 90 days or less during the month

Fiscal Year - 2011
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Oct 2010N/A56
Nov 2010N/A35
Dec 2010N/A40
Jan 2011N/A55
Feb 2011N/A46
Mar 2011N/A42
Apr 2011N/A60
May 2011N/A60
Jun 2011N/A41
Jul 2011N/A43
Aug 2011N/A58
Sep 2011N/A74

FY 2011 Total: 610

Total number of OIR 510(k) decisions made during the month

Fiscal Year - 2011
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Oct 2010N/A71
Nov 2010N/A41
Dec 2010N/A50
Jan 2011N/A58
Feb 2011N/A53
Mar 2011N/A56
Apr 2011N/A68
May 2011N/A69
Jun 2011N/A48
Jul 2011N/A49
Aug 2011N/A66
Sep 2011N/A85

FY 2011 Total: 714


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.