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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 - 2010

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TimeTargetPercent
Oct 20099091
Nov 20099092
Dec 20099090
Jan 20109086
Feb 20109082
Mar 20109086
Apr 20109089
May 20109088
Jun 20109088
Jul 20109092
Aug 20109089
Sep 20109087

FY 2010 Total: 89%

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

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A249
Nov 2009N/A217
Dec 2009N/A257
Jan 2010N/A180
Feb 2010N/A171
Mar 2010N/A269
Apr 2010N/A256
May 2010N/A198
Jun 2010N/A244
Jul 2010N/A248
Aug 2010N/A231
Sep 2010N/A186

FY 2010 Total: 2,706

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

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A273
Nov 2009N/A235
Dec 2009N/A286
Jan 2010N/A209
Feb 2010N/A208
Mar 2010N/A311
Apr 2010N/A288
May 2010N/A224
Jun 2010N/A277
Jul 2010N/A271
Aug 2010N/A259
Sep 2010N/A213

FY 2010 Total: 3,054

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.