Đang chuẩn bị liên kết để tải về tài liệu:
Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program

The CGAP measure of relative macroeconomic performance is attractive for a number of reasons. First, it is based on changes in real GDP, a fundamental variable that should be highly correlated with changes in underlying welfare. Second, our measure should not be unduly sensitive to the stage of an economy’s business cycle going into the crisis. An economy that was overheating prior to 2008 would tend to have a positive unexplained component at that point in time, but it is only the unexplained component during the crisis itself that is considered in our analysis. Third, this measure should be. | Guidance for Industry Third Parties and Food and Drug __Administration Staff_ Medical Device ISO 13485 2003 Voluntary Audit Report Submission Pilot Program Document issued on March 19 2012 The draft of this document was issued on May 20 2010. OMB control number 0910-0700 Expiration Date 02 28 2015 See additional PRA statement at the end of this guidance For questions regarding this document contact Kimberly A. Trautman CDRH at 301-796-5515 or by email at Kimberly.Trautman@fda.hhs.gov or the Center for Biologics Evaluation and Research CBER the Office of Communication Outreach and Development OCOD at 1-800835-4709 or 301-827-1800 or ocod@fda.hhs.gov. cDda T rhJ U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Contains Nonbinding Recommendations Preface Public Comment You may submit comments and suggestions at any time for Agency consideration. Submit electronic comments to http www.regulations.gov. Submit written comments to the Division of Dockets Management Food and Drug Administration 5630 Fishers Lane rm. 1061 HFA-305 Rockville MD 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet. You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 301847-8149 to receive a hard copy. Please use the document number 1746 to identify the guidance you are requesting. Copies of the guidance are also available from Office of Communication Outreach and Development OCOD HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike Suite 200N Rockville MD 20852-1448 Phone 800-835-4709 or .