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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 2013 Target: 90% of 40 documents by 9/30/2013

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 - 2013

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Cumulative FY 2013 Target: 90% of 40 documents by 9/30/2013

TimeTargetCumulative Percent
Oct 2012N/A8
Nov 2012N/A10
Dec 2012N/A28
Jan 2013N/A45
Feb 2013N/A58
Mar 2013N/A75
Apr 2013N/A83
May 2013N/A93
Jun 2013N/A98
Jul 2013N/A103
Aug 2013N/A113
Sep 2013N/A123

FY 2013 Overall: 123%

Cumulative number of guidance documents cleared by OCD

Fiscal Year - 2013
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TimeTargetCumulative Number
Oct 2012N/A3
Nov 2012N/A4
Dec 2012N/A11
Jan 2013N/A18
Feb 2013N/A23
Mar 2013N/A30
Apr 2013N/A33
May 2013N/A37
Jun 2013N/A39
Jul 2013N/A41
Aug 2013N/A45
Sep 2013N/A49

FY 2013 Total: 40

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

Fiscal Year - 2013
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TimeTargetTotal Number
Oct 2012N/A40
Nov 2012N/A40
Dec 2012N/A40
Jan 2013N/A40
Feb 2013N/A40
Mar 2013N/A40
Apr 2013N/A40
May 2013N/A40
Jun 2013N/A40
Jul 2013N/A40
Aug 2013N/A40
Sep 2013N/A40

FY 2013 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.