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

Fiscal Year - 2013

Time	Target	Number
Oct 2012	N/A	45
Nov 2012	N/A	38
Dec 2012	N/A	69
Jan 2013	N/A	TBD
Feb 2013	N/A	TBD
Mar 2013	N/A	TBD
Apr 2013	N/A	TBD
May 2013	N/A	TBD
Jun 2013	N/A	TBD
Jul 2013	N/A	TBD
Aug 2013	N/A	TBD
Sep 2013	N/A	TBD

FY 2013 YTD: 152

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

Fiscal Year - 2013

Time	Target	Number
Oct 2012	N/A	45
Nov 2012	N/A	43
Dec 2012	N/A	71
Jan 2013	N/A	TBD
Feb 2013	N/A	TBD
Mar 2013	N/A	TBD
Apr 2013	N/A	TBD
May 2013	N/A	TBD
Jun 2013	N/A	TBD
Jul 2013	N/A	TBD
Aug 2013	N/A	TBD
Sep 2013	N/A	TBD

FY 2013 YTD: 159