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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 - 2012

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TimeTargetPercent
Oct 20119095
Nov 20119095
Dec 20119097
Jan 20129094
Feb 20129098
Mar 20129094
Apr 20129099
May 20129094
Jun 20129097
Jul 20129097
Aug 20129099
Sep 20129097

FY 2012 Overall: 96%

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A198
Nov 2011N/A193
Dec 2011N/A251
Jan 2012N/A173
Feb 2012N/A199
Mar 2012N/A212
Apr 2012N/A201
May 2012N/A229
Jun 2012N/A233
Jul 2012N/A211
Aug 2012N/A207
Sep 2012N/A199

FY 2012 Total: 2,506

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A208
Nov 2011N/A203
Dec 2011N/A258
Jan 2012N/A185
Feb 2012N/A204
Mar 2012N/A226
Apr 2012N/A204
May 2012N/A243
Jun 2012N/A241
Jul 2012N/A218
Aug 2012N/A209
Sep 2012N/A205

FY 2012 Total: 2,604

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.