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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 - 2010

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TimeTargetPercent
Oct 20099079
Nov 20099093
Dec 20099081
Jan 20109085
Feb 20109096
Mar 201090100
Apr 20109093
May 201090100
Jun 201090100
Jul 20109096
Aug 20109096
Sep 20109096

FY 2010 Overall: 93%

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

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A22
Nov 2009N/A26
Dec 2009N/A25
Jan 2010N/A11
Feb 2010N/A24
Mar 2010N/A32
Apr 2010N/A26
May 2010N/A25
Jun 2010N/A22
Jul 2010N/A25
Aug 2010N/A26
Sep 2010N/A22

FY 2010 Total: 286

Total number of IVD decision summaries posted during the month

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A28
Nov 2009N/A28
Dec 2009N/A31
Jan 2010N/A13
Feb 2010N/A25
Mar 2010N/A32
Apr 2010N/A28
May 2010N/A25
Jun 2010N/A22
Jul 2010N/A26
Aug 2010N/A27
Sep 2010N/A23

FY 2010 Total: 308

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.