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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 - 2013

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TimeTargetPercent
Oct 20129096
Nov 20129095
Dec 20129097
Jan 20139095
Feb 20139096
Mar 20139098
Apr 20139096
May 20139093
Jun 20139092
Jul 20139095
Aug 20139091
Sep 20139094

FY 2013 Total: 95%

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

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A218
Nov 2012N/A190
Dec 2012N/A218
Jan 2013N/A163
Feb 2013N/A189
Mar 2013N/A225
Apr 2013N/A194
May 2013N/A202
Jun 2013N/A151
Jul 2013N/A188
Aug 2013N/A204
Sep 2013N/A154

FY 2013 Total: 2,296

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

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A227
Nov 2012N/A200
Dec 2012N/A225
Jan 2013N/A172
Feb 2013N/A197
Mar 2013N/A230
Apr 2013N/A203
May 2013N/A217
Jun 2013N/A165
Jul 2013N/A198
Aug 2013N/A224
Sep 2013N/A164

FY 2013 Total: 2,422

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.