• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

Percent of Office of In Vitro Diagnostics and Radiological Health (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

Skip graphic and jump to text data

TimeTargetPercent
Oct 201290100
Nov 20129088
Dec 20129097
Jan 20139097
Feb 20139098
Mar 20139098
Apr 201390100
May 20139094
Jun 20139093
Jul 20139095
Aug 20139092
Sep 20139096

FY 2013 Overall: 96%

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

Fiscal Year - 2013
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2012N/A45
Nov 2012N/A38
Dec 2012N/A69
Jan 2013N/A61
Feb 2013N/A63
Mar 2013N/A64
Apr 2013N/A58
May 2013N/A59
Jun 2013N/A57
Jul 2013N/A57
Aug 2013N/A61
Sep 2013N/A52

FY 2013 Total: 684

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

Fiscal Year - 2013
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2012N/A45
Nov 2012N/A43
Dec 2012N/A71
Jan 2013N/A63
Feb 2013N/A64
Mar 2013N/A65
Apr 2013N/A58
May 2013N/A63
Jun 2013N/A61
Jul 2013N/A60
Aug 2013N/A66
Sep 2013N/A54

FY 2013 Total: 728

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.