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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.

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

Fiscal Year - 2010

Time	Target	Number
Oct 2009	N/A	249
Nov 2009	N/A	217
Dec 2009	N/A	257
Jan 2010	N/A	180
Feb 2010	N/A	171
Mar 2010	N/A	269
Apr 2010	N/A	256
May 2010	N/A	198
Jun 2010	N/A	244
Jul 2010	N/A	248
Aug 2010	N/A	231
Sep 2010	N/A	186

FY 2010 Total: 2,706

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

Fiscal Year - 2010

Time	Target	Number
Oct 2009	N/A	273
Nov 2009	N/A	235
Dec 2009	N/A	286
Jan 2010	N/A	209
Feb 2010	N/A	208
Mar 2010	N/A	311
Apr 2010	N/A	288
May 2010	N/A	224
Jun 2010	N/A	277
Jul 2010	N/A	271
Aug 2010	N/A	259
Sep 2010	N/A	213

FY 2010 Total: 3,054