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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 December 31, 2012

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

Cumulative number of guidance documents cleared by OCD

Fiscal Year - 2013

Time	Target	Cumulative Number
Oct 2012	N/A	3
Nov 2012	N/A	4
Dec 2012	N/A	10
Jan 2013	N/A	TBD
Feb 2013	N/A	TBD
Mar 2013	N/A	TBD
Apr 2013	N/A	TBD
May 2012	N/A	TBD
Jun 2013	N/A	TBD
Jul 2013	N/A	TBD
Aug 2013	N/A	TBD
Sep 2013	N/A	TBD

FY 2013 YTD: 9

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

Fiscal Year - 2013

Time	Target	Total Number
Oct 2012	N/A	40
Nov 2012	N/A	40
Dec 2012	N/A	40
Jan 2013	N/A	40
Feb 2013	N/A	40
Mar 2013	N/A	40
Apr 2013	N/A	40
May 2012	N/A	40
Jun 2013	N/A	40
Jul 2013	N/A	40
Aug 2013	N/A	40
Sep 2013	N/A	40

FY 2013 YTD: 40