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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 2011 Target: 90% of 40 documents by 9/30/2011

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 - 2011

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Cumulative FY 2011 Target: 90% of 40 documents by 9/30/2011

TimeCumulative Annual TargetCumulative Percent
Oct 2010900
Nov 2010908
Dec 20109015
Jan 20119015
Feb 20119018
Mar 20119040
Apr 20119045
May 20119070
Jun 20119073
Jul 20119088
Aug 20119098
Sep 201190110

FY 2011 Overall: 110%

Cumulative number of guidance documents cleared by OCD

Fiscal Year - 2011
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TimeTargetCumulative Number
Oct 2010N/A0
Nov 2010N/A3
Dec 2010N/A6
Jan 2011N/A6
Feb 2011N/A7
Mar 2011N/A16
Apr 2011N/A18
May 2011N/A28
Jun 2011N/A29
Jul 2011N/A35
Aug 2011N/A39
Sep 2011N/A44

FY 2011 Total: 44

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

Fiscal Year - 2011
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TimeTargetTotal Number
Oct 2010N/A40
Nov 2010N/A40
Dec 2010N/A40
Jan 2011N/A40
Feb 2011N/A40
Mar 2011N/A40
Apr 2011N/A40
May 2011N/A40
Jun 2011N/A40
Jul 2011N/A40
Aug 2011N/A40
Sep 2011N/A40

FY 2011 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.