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U.S. Department of Health and Human Services

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Percent of Office of Device Evaluation (ODE) 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 20099092
Nov 20099092
Dec 20099090
Jan 20109088
Feb 20109082
Mar 20109088
Apr 20109090
May 20109090
Jun 20109090
Jul 20109094
Aug 20109091
Sep 20109091

FY 2010 Overall: 90%

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

Fiscal Year - 2010
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Oct 2009N/A223
Nov 2009N/A190
Dec 2009N/A227
Jan 2010N/A169
Feb 2010N/A139
Mar 2010N/A207
Apr 2010N/A208
May 2010N/A164
Jun 2010N/A202
Jul 2010N/A207
Aug 2010N/A178
Sep 2010N/A158

FY 2010 Total: 2,272

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

Fiscal Year - 2010
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Oct 2009N/A243
Nov 2009N/A206
Dec 2009N/A253
Jan 2010N/A193
Feb 2010N/A169
Mar 2010N/A234
Apr 2010N/A230
May 2010N/A183
Jun 2010N/A224
Jul 2010N/A221
Aug 2010N/A196
Sep 2010N/A174

FY 2010 Total: 2,526


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.