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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 - 2010

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Oct 20099087
Nov 20099093
Dec 20099091
Jan 20109069
Feb 20109082
Mar 20109081
Apr 20109083
May 20109083
Jun 20109079
Jul 20109082
Aug 20109084
Sep 20109072

FY 2010 Overall: 82%

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

Fiscal Year - 2010
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Oct 2009N/A26
Nov 2009N/A27
Dec 2009N/A30
Jan 2010N/A11
Feb 2010N/A32
Mar 2010N/A62
Apr 2010N/A48
May 2010N/A34
Jun 2010N/A42
Jul 2010N/A41
Aug 2010N/A53
Sep 2010N/A28

FY 2010 Total: 434

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

Fiscal Year - 2010
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Oct 2009N/A30
Nov 2009N/A29
Dec 2009N/A33
Jan 2010N/A16
Feb 2010N/A39
Mar 2010N/A77
Apr 2010N/A58
May 2010N/A41
Jun 2010N/A53
Jul 2010N/A50
Aug 2010N/A63
Sep 2010N/A39

FY 2010 Total: 528


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.