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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 December 31, 2012

• FY 2010
• FY 2011
• FY 2012
• FY 2013
• All

Cumulative number of guidance documents cleared by OCD

Fiscal Year - 2011

Time	Target	Cumulative Number
Oct 2010	N/A	0
Nov 2010	N/A	3
Dec 2010	N/A	6
Jan 2011	N/A	6
Feb 2011	N/A	7
Mar 2011	N/A	16
Apr 2011	N/A	18
May 2011	N/A	28
Jun 2011	N/A	29
Jul 2011	N/A	35
Aug 2011	N/A	39
Sep 2011	N/A	44

FY 2011 Total: 44

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

Fiscal Year - 2011

Time	Target	Total Number
Oct 2010	N/A	40
Nov 2010	N/A	40
Dec 2010	N/A	40
Jan 2011	N/A	40
Feb 2011	N/A	40
Mar 2011	N/A	40
Apr 2011	N/A	40
May 2011	N/A	40
Jun 2011	N/A	40
Jul 2011	N/A	40
Aug 2011	N/A	40
Sep 2011	N/A	40

FY 2011 Total: 40