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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 December 31, 2012
Fiscal Year - 2010
Cumulative FY 2010 Target: 90% of 40 documents by 9/30/2010
| Time | Adjusted Monthly Target | Cumulative Percent |
|---|---|---|
| Oct 2009 | 90 | 13 |
| Nov 2009 | 90 | 18 |
| Dec 2009 | 90 | 25 |
| Jan 2010 | 90 | 25 |
| Feb 2010 | 90 | 28 |
| Mar 2010 | 90 | 33 |
| Apr 2010 | 90 | 35 |
| May 2010 | 90 | 40 |
| Jun 2010 | 90 | 45 |
| Jul 2010 | 90 | 55 |
| Aug 2010 | 90 | 68 |
| Sep 2010 | 90 | 98 |
FY 2010 Overall: 98%
Cumulative number of guidance documents cleared by OCD
Fiscal Year - 2010
| Time | Target | Cumulative Number |
|---|---|---|
| Oct 2009 | N/A | 5 |
| Nov 2009 | N/A | 7 |
| Dec 2009 | N/A | 10 |
| Jan 2010 | N/A | 10 |
| Feb 2010 | N/A | 11 |
| Mar 2010 | N/A | 13 |
| Apr 2010 | N/A | 14 |
| May 2010 | N/A | 16 |
| Jun 2010 | N/A | 18 |
| Jul 2010 | N/A | 22 |
| Aug 2010 | N/A | 27 |
| Sep 2010 | N/A | 39 |
FY 2010 Total: 39
Total number of guidance documents to be cleared by end of fiscal year
Fiscal Year - 2010
| Time | Target | Total Number |
|---|---|---|
| Oct 2009 | N/A | 40 |
| Nov 2009 | N/A | 40 |
| Dec 2009 | N/A | 40 |
| Jan 2010 | N/A | 40 |
| Feb 2010 | N/A | 40 |
| Mar 2010 | N/A | 40 |
| Apr 2010 | N/A | 40 |
| May 2010 | N/A | 40 |
| Jun 2010 | N/A | 40 |
| Jul 2010 | N/A | 40 |
| Aug 2010 | N/A | 40 |
| Sep 2010 | N/A | 40 |
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.
