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U.S. Department of Health and Human Services

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Percent of CDRH (ODE and 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 - 2013

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TimeTargetPercent
Oct 20129097
Nov 20129094
Dec 20129097
Jan 20139095
Feb 20139097
Mar 20139098
Apr 20139097
May 20139093
Jun 20139092
Jul 20139095
Aug 20139091
Sep 20139094

FY 2013 Overall: 95%

Number of CDRH (ODE and OIR) 510(k) decisions made in 90 days or less during the month (meeting goal)

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A263
Nov 2012N/A228
Dec 2012N/A287
Jan 2013N/A224
Feb 2013N/A252
Mar 2013N/A289
Apr 2013N/A252
May 2013N/A261
Jun 2013N/A208
Jul 2013N/A245
Aug 2013N/A265
Sep 2013N/A206

FY 2013 Total: 2,980

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

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A272
Nov 2012N/A243
Dec 2012N/A296
Jan 2013N/A235
Feb 2013N/A261
Mar 2013N/A295
Apr 2013N/A261
May 2013N/A280
Jun 2013N/A226
Jul 2013N/A258
Aug 2013N/A290
Sep 2013N/A218

FY 2013 Total: 3,135

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.