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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 December 31, 2012

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• FY 2011
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Number of OIR 510(k) decisions made in 90 days or less during the month

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	56
Nov 2010	N/A	35
Dec 2010	N/A	40
Jan 2011	N/A	55
Feb 2011	N/A	46
Mar 2011	N/A	42
Apr 2011	N/A	60
May 2011	N/A	60
Jun 2011	N/A	41
Jul 2011	N/A	43
Aug 2011	N/A	58
Sep 2011	N/A	74

FY 2011 Total: 610

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

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	71
Nov 2010	N/A	41
Dec 2010	N/A	50
Jan 2011	N/A	58
Feb 2011	N/A	53
Mar 2011	N/A	56
Apr 2011	N/A	68
May 2011	N/A	69
Jun 2011	N/A	48
Jul 2011	N/A	49
Aug 2011	N/A	66
Sep 2011	N/A	85

FY 2011 Total: 714