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Percent of 510(k) In Vitro Diagnostics (IVD) decision summaries posted on the web within the 45 day timeframe during the month

Dictionary: 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.

This measure quantifies OIVD’s ability to inform the public about devices cleared through the 510(k) process. Expedient posting of review memos will provide up to date information to the public.

• FY 2010
• FY 2011
• FY 2012
• All

Number of IVD decision summaries posted within 45 day timeframe during the month

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	27
Nov 2010	N/A	16
Dec 2010	N/A	37
Jan 2011	N/A	28
Feb 2011	N/A	22
Mar 2011	N/A	17
Apr 2011	N/A	28
May 2011	N/A	33
Jun 2011	N/A	22
Jul 2011	N/A	22
Aug 2011	N/A	32
Sep 2011	N/A	25

FY 2011 Total: 309

Total number of IVD decision summaries posted during the month

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	28
Nov 2010	N/A	19
Dec 2010	N/A	44
Jan 2011	N/A	28
Feb 2011	N/A	22
Mar 2011	N/A	17
Apr 2011	N/A	28
May 2011	N/A	34
Jun 2011	N/A	24
Jul 2011	N/A	26
Aug 2011	N/A	33
Sep 2011	N/A	25

FY 2011 Total: 328