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U.S. Department of Health and Human Services

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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.

Fiscal Year - 2012

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TimeTargetPercent
Oct 20119095
Nov 20119094
Dec 20119078
Jan 201290100
Feb 201290100
Mar 201290100
Apr 20129097

FY 2012 YTD: 92%

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A19
Nov 2011N/A17
Dec 2011N/A39
Jan 2012N/A18
Feb 2012N/A20
Mar 2012N/A19
Apr 2012N/A33

FY 2012 YTD: 165

Total number of IVD decision summaries posted during the month

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A20
Nov 2011N/A18
Dec 2011N/A50
Jan 2012N/A18
Feb 2012N/A20
Mar 2012N/A19
Apr 2012N/A34

FY 2012 YTD: 179

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.