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Humanitarian Device Exemption
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1	Stanford University HRPP Policy Guidance Humanitarian Use Device (HUD) Add to Reading List Source URL: humansubjects.stanford.edu Language: English - Date: 2016-04-12 01:21:50 Food and Drug Administration Health Ethics Design of experiments Drug safety Humanitarian Device Exemption Institutional review board HDE Hud
2	The FDA Medical Device User Fee Program: MDUFA IV Reauthorization Add to Reading List Source URL: www.fas.org Language: English - Date: 2016-06-09 19:26:25 Food and Drug Administration Health Medicine Federal Food Drug and Cosmetic Act Prescription Drug User Fee Act Center for Devices and Radiological Health Medical device Humanitarian Device Exemption Laboratory Developed Test Single Use Medical Device Reprocessing Food and Drug Administration Modernization Act
3	IMDRF Presentation - Jurisdictional update - US Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2015-09-07 20:17:26 Food and Drug Administration Health Medicine Center for Devices and Radiological Health Medical device Humanitarian Device Exemption
4	This document is scheduled to be published in the Federal Register onand available online at http://federalregister.gov/a, and on FDsys.govP DEPARTMENT OF HEALTH AND HUMAN SERVICES Add to Reading List Source URL: s3.amazonaws.com Language: English - Date: 2015-05-15 08:45:26 Technology Medical device Investigational Device Exemption Title 21 of the Code of Federal Regulations Premarket approval Center for Devices and Radiological Health Humanitarian Device Exemption Clinical trial ClinicalTrials.gov Food and Drug Administration Medicine Health
5	Fact Sheet: 50cc SynCardia Total Artificial Heart Background The 50cc SynCardia Total Artificial Heart is a smaller version of the 70cc SynCardia temporary Total Artificial Heart that received FDA approval as a bridge to Add to Reading List Source URL: www.syncardia.com Language: English - Date: 2013-02-27 17:00:33 Interventional cardiology Artificial heart Organ transplants Destination therapy Humanitarian Device Exemption Heart transplantation Medicine Implants Cardiology
6	Microsoft PowerPoint - LASIK.ppt [Read-Only] Add to Reading List Source URL: www.fda.gov Language: English - Date: 2008-05-08 09:28:51 Technology Premarket approval Medical device Center for Devices and Radiological Health Food and Drug Administration Modernization Act Humanitarian Device Exemption Title 21 of the Code of Federal Regulations Federal Food Drug and Cosmetic Act Investigational Device Exemption Food and Drug Administration Medicine Health
7	Agenda for Quarterly Meeting on MDUFA III (FY[removed]Performance November 18, [removed]:00 A.M. Welcome. Barbara Zimmerman, CDRH-ODE. Guidance Development • Add to Reading List Source URL: www.fda.gov Language: English Health Premarket approval Investigational Device Exemption Center for Devices and Radiological Health Medical device Humanitarian Device Exemption Unique Device Identification Food and Drug Administration Medicine Technology
8	NWX-HHS-FDA Moderator: Irene Aihie[removed]:00 pm CT Confirmation # [removed]Page 1 Add to Reading List Source URL: www.fda.gov Language: English Health Medical device Premarket approval Center for Devices and Radiological Health International Multilateral Partnership Against Cyber Threats Humanitarian Device Exemption Computer security Food and Drug Administration Medicine Technology
9	Microsoft Word - H120003.Approval_Order[removed]doc Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-09-04 16:11:59 Technology Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Medical device Adverse event Humanitarian Device Exemption Title 21 of the Code of Federal Regulations Food and Drug Administration Medicine Health
10	DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-09-10 12:42:28 Technology Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Medical device Title 21 of the Code of Federal Regulations Humanitarian Device Exemption Adverse event Food and Drug Administration Medicine Health

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