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Unique Device Identification
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161	This graph depicts what happens to an adverse event report that is submitted to FDA. First, FDA may receive one of two types of reports: mandatory or voluntary. A mandatory report is sent to FDA by a manufacturer, import Add to Reading List Source URL: www.fda.gov. Language: English Food and Drug Administration Clinical research Pharmaceutical industry Therapeutics Adverse event Adverse Event Reporting System Unique Device Identification Pharmaceutical sciences Pharmacology Research
162	November 7, 2012 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm[removed]Rockville, MD[removed]Re: [Docket No. FDA-2011-N[removed]Comments on the Proposed Rule, “Unique Device Add to Reading List Source URL: npalliance.org Language: English - Date: 2012-11-08 18:07:25 Pharmaceutical sciences Unique Device Identification Medical device MedWatch Adverse Event Reporting System Electronic health record Global Harmonization Task Force Clinical trial Food and Drug Administration Medicine Health
163	Form 3 - CONTACT INFORMATION When there is a potential food recall, the US Food and Drug Administration Office of Regulatory Affairs must be notified. They will help with the recall process and will determine the recall Add to Reading List Source URL: onfarmfoodsafety.org Language: English - Date: 2011-03-27 16:11:33 Office of Regulatory Affairs Pharmacology Product recall Drug recall Unique Device Identification Food and Drug Administration Pharmaceutical sciences Clinical research
164	HIBCC to Sponsor the Annual UDI Conference! October 28-29, 2014 ♦ Baltimore, MD Add to Reading List Source URL: www.hibcc.org Language: English - Date: 2014-08-19 16:58:19 Food and Drug Administration Pharmacology Therapeutics United States Public Health Service Unique Device Identification Pharmaceutical sciences Clinical research Clinical pharmacology
165	DEPARTMENT OF HEALTH & HUMAN SERVICES June 24, 2014 Public Health Service Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-07-23 14:57:59 Technology Center for Devices and Radiological Health Premarket approval Medical device Federal Food Drug and Cosmetic Act Title 21 of the Code of Federal Regulations Adverse event Investigational Device Exemption Unique Device Identification Food and Drug Administration Medicine Health
166	P130030_Approval_Order.pdf Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-07-23 08:36:17 Health Center for Devices and Radiological Health Premarket approval Medical device Federal Food Drug and Cosmetic Act Title 21 of the Code of Federal Regulations Adverse event Investigational Device Exemption Unique Device Identification Food and Drug Administration Medicine Technology
167	July 3, 2013 The Honorable Sylvia Mathews Burwell Director Office of Management and Budget 243 Old Executive Office Building Washington, DC 20503 Add to Reading List Source URL: npalliance.org Language: English - Date: 2013-07-08 13:17:57 Pharmaceutical sciences Medical equipment Unique Device Identification Medical device National Research Center for Women and Families Medicine Food and Drug Administration Health
168	Updated: May 5, 2014 UDI Implementation: Are You Ready? In a move to improve patient safety and healthcare business processes, the United States Federal Drug Administration (US FDA) passed a regulation late last year th Add to Reading List Source URL: www.gs1ca.org Language: English - Date: 2014-09-24 11:57:18 Universal identifiers Food and Drug Administration Unique Device Identification Standards organizations GS1 Canada GS1 Global Trade Item Number International Article Number Medical device Identification Identifiers Barcodes
169	August 12, 2014 The Honorable Ron Wyden Chairman Committee on Finance United States Senate Add to Reading List Source URL: ehrintelligence.com Language: English - Date: 2014-08-12 09:54:01 International standards Food and Drug Administration Unique Device Identification Electronic health record Medical terms American College of Cardiology Medicare Medical device Office of the National Coordinator for Health Information Technology Medicine Health Health informatics
170	Healthcare GTIN Allocation Rules Healthcare GTIN Allocation Rules GS1 Global Healthcare User Group Compliments of: Add to Reading List Source URL: www.pips.com Language: English - Date: 2012-10-17 09:12:24 Universal identifiers Electronic commerce Standards organizations Global Trade Item Number International Article Number Check digit GS1 Unique Device Identification Numbering scheme Identification Identifiers Barcodes

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