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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 2012 Target: 90% of 40 documents by 9/30/2012

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 - 2012

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Cumulative FY 2012 Target: 90% of 40 documents by 9/30/2012

TimeCumulative Annual TargetCumulative Percent
Oct 2011908
Nov 20119020
Dec 20119028
Jan 20129033
Feb 20129043
Mar 20129050
Apr 20129055
May 20129065
Jun 20129073
Jul 20129078
Aug 201290100
Sep 201290115

FY 2012 Cumulative Total: 115%

Cumulative number of guidance documents cleared by OCD

Fiscal Year - 2012
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TimeTargetCumulative Number
Oct 2011N/A3
Nov 2011N/A10
Dec 2011N/A12
Jan 2012N/A14
Feb 2012N/A16
Mar 2012N/A19
Apr 2012N/A21
May 2012N/A24
Jun 2012N/A29
Jul 2012N/A36
Aug 2012N/A40
Sep 2012N/A46

FY 2012 Total: 46

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

Fiscal Year - 2012
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TimeTargetTotal Number
Oct 2011N/A40
Nov 2011N/A40
Dec 2011N/A40
Jan 2012N/A40
Feb 2012N/A40
Mar 2012N/A40
Apr 2012N/A40
May 2012N/A40
Jun 2012N/A40
Jul 2012N/A40
Aug 2012N/A40
Sep 2012N/A40

FY 2012 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.