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U.S. Department of Health and Human Services

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Cumulative percent of guidance documents for which a final action (i.e. issue as final or withdraw) was taken by CDRH (1)

Cumulative CY 2012 Target: 50% of 22 documents by 12/31/2012

Dictionary: 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. Draft guidance documents are issued for public comment before being implemented. Final guidance documents are implemented upon issuance. Withdrawn documents are removed from public access because they no longer reflect current thinking. Under this measure CDRH plans to take final action on guidance documents available on the web as draft, meaning that CDRH will issue a final guidance or withdraw the existing draft.

Fiscal Year - 2012

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Cumulative CY 2012 Target: 50% of 22 documents by 12/31/2012

TimeCumulative Annual TargetCumulative Percent
Jan 2012500
Feb 2012500
Mar 2012500
Apr 20125014
May 20125014
Jun 20125014
Jul 20125014
Aug 20125014
Sep 20125023
Oct 20125023
Nov 20125023
Dec 20125023

Calendar Year 2012 Cumulative Total: 23%

Footnotes

  • (1) Measure is based on calendar year starting January 2012, in line with CDRH 2012 Strategic Priorities action items.

Cumulative number of guidance documents for which a final action (i.e. issue as final or withdraw) was taken by CDRH

Fiscal Year - 2012
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TimeTargetCumulative Number
Jan 2012N/A0
Feb 2012N/A0
Mar 2012N/A0
Apr 2012N/A3
May 2012N/A3
Jun 2012N/A3
Jul 2012N/A3
Aug 2012N/A3
Sep 2012N/A5
Oct 2012N/A5
Nov 2012N/A5
Dec 2012N/A5

FY 2012 Total: 5

Total number of draft CDRH guidance documents issued between February 27, 1997 and September 30, 2009 (as of 1/1/2012)

Fiscal Year - 2012
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TimeTargetTotal Number
Jan 2012N/A22
Feb 2012N/A22
Mar 2012N/A22
Apr 2012N/A22
May 2012N/A22
Jun 2012N/A22
Jul 2012N/A22
Aug 2012N/A22
Sep 2012N/A22
Oct 2012N/A22
Nov 2012N/A22
Dec 2012N/A22

Calendar Year 2012 Total: 22

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.