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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 - 2011

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TimeTargetPercent
Oct 20109096
Nov 20109084
Dec 20109084
Jan 201190100
Feb 201190100
Mar 201190100
Apr 201190100
May 20119097
Jun 20119092
Jul 20119085
Aug 20119097
Sep 201190100

FY 2011 Overall: 94%

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A27
Nov 2010N/A16
Dec 2010N/A37
Jan 2011N/A28
Feb 2011N/A22
Mar 2011N/A17
Apr 2011N/A28
May 2011N/A33
Jun 2011N/A22
Jul 2011N/A22
Aug 2011N/A32
Sep 2011N/A25

FY 2011 Total: 309

Total number of IVD decision summaries posted during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A28
Nov 2010N/A19
Dec 2010N/A44
Jan 2011N/A28
Feb 2011N/A22
Mar 2011N/A17
Apr 2011N/A28
May 2011N/A34
Jun 2011N/A24
Jul 2011N/A26
Aug 2011N/A33
Sep 2011N/A25

FY 2011 Total: 328

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.