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U.S. Department of Health and Human Services

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Cumulative percent of guidance documents cleared by Office of the Center Director (OCD)

Cumulative FY 2010 Target: 90% of 40 documents by 9/30/2010

Dictionary: All CDRH guidance documents require OCD clearance prior to publishing. Guidance documents are documents prepared for CDRH staff, regulated industry and the public that relate to (1) the processing, content, and evaluation of regulatory submissions, (2) the design, production, manufacturing, and testing of regulated products, and (3) the inspection and enforcement procedures. Guidance documents cleared by OCD assure that good guidance practice (GGP) policy has been fulfilled. Alternative approaches may be used pending they satisfy the requirements of the applicable statute, regulations, or both. A proposed list of guidance to be developed is posted every year for public comment, as required by the Medical Device User Fee Modernization Act (MDUFMA).

Information is current as of September 30, 2013

Fiscal Year - 2010

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Cumulative FY 2010 Target: 90% of 40 documents by 9/30/2010

TimeAdjusted Monthly TargetCumulative Percent
Oct 20099013
Nov 20099018
Dec 20099025
Jan 20109025
Feb 20109028
Mar 20109033
Apr 20109035
May 20109040
Jun 20109045
Jul 20109055
Aug 20109068
Sep 20109098

FY 2010 Overall: 98%

Cumulative number of guidance documents cleared by OCD

Fiscal Year - 2010
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TimeTargetCumulative Number
Oct 2009N/A5
Nov 2009N/A7
Dec 2009N/A10
Jan 2010N/A10
Feb 2010N/A11
Mar 2010N/A13
Apr 2010N/A14
May 2010N/A16
Jun 2010N/A18
Jul 2010N/A22
Aug 2010N/A27
Sep 2010N/A39

FY 2010 Total: 39

Total number of guidance documents to be cleared by end of fiscal year

Fiscal Year - 2010
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TimeTargetTotal Number
Oct 2009N/A40
Nov 2009N/A40
Dec 2009N/A40
Jan 2010N/A40
Feb 2010N/A40
Mar 2010N/A40
Apr 2010N/A40
May 2010N/A40
Jun 2010N/A40
Jul 2010N/A40
Aug 2010N/A40
Sep 2010N/A40

FY 2010 Total: 40

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.