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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 December 31, 2012

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

Cumulative number of guidance documents cleared by OCD

Fiscal Year - 2012

Time	Target	Cumulative Number
Oct 2011	N/A	3
Nov 2011	N/A	10
Dec 2011	N/A	12
Jan 2012	N/A	14
Feb 2012	N/A	16
Mar 2012	N/A	19
Apr 2012	N/A	21
May 2012	N/A	24
Jun 2012	N/A	29
Jul 2012	N/A	36
Aug 2012	N/A	40
Sep 2012	N/A	46

FY 2012 Total: 46

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

Fiscal Year - 2012

Time	Target	Total Number
Oct 2011	N/A	40
Nov 2011	N/A	40
Dec 2011	N/A	40
Jan 2012	N/A	40
Feb 2012	N/A	40
Mar 2012	N/A	40
Apr 2012	N/A	40
May 2012	N/A	40
Jun 2012	N/A	40
Jul 2012	N/A	40
Aug 2012	N/A	40
Sep 2012	N/A	40

FY 2012 Total: 40