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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 Draft guidance documents are issued for public comment before being implemented.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 Withdrawn documents are removed from public access because they no longer reflect current thinking.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.

• FY 2012
• All

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

Time	Target	Cumulative Number
Jan 2012	N/A	0
Feb 2012	N/A	0
Mar 2012	N/A	0
Apr 2012	N/A	3
May 2012	N/A	3
Jun 2012	N/A	3
Jul 2012	N/A	3
Aug 2012	N/A	3
Sep 2012	N/A	5
Oct 2012	N/A	5
Nov 2012	N/A	5
Dec 2012	N/A	5

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

Time	Target	Total Number
Jan 2012	N/A	22
Feb 2012	N/A	22
Mar 2012	N/A	22
Apr 2012	N/A	22
May 2012	N/A	22
Jun 2012	N/A	22
Jul 2012	N/A	22
Aug 2012	N/A	22
Sep 2012	N/A	22
Oct 2012	N/A	22
Nov 2012	N/A	22
Dec 2012	N/A	22

Calendar Year 2012 Total: 22