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Humanitarian Device Exemption
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11	07.__H130005.A002_APPROVAL_ORDER[removed]pdf Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2014-08-22 15:51:34 Technology Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Medical device Title 21 of the Code of Federal Regulations Adverse event Humanitarian Device Exemption Unique Device Identification Food and Drug Administration Medicine Health
12	RERC on Accessible Medical Instrumentation Add to Reading List Source URL: www.fda.gov Language: English Health Premarket approval Investigational Device Exemption Medical device Center for Devices and Radiological Health Humanitarian Device Exemption Usability Human factors Food and Drug Administration Medicine Technology
13	Humanitarian Device Exemptions Nicole Wolanski CAPT, USPHS Director, Premarket Approval Section Add to Reading List Source URL: www.fda.gov Language: English Health Humanitarian Device Exemption Premarket approval Clinical trial Center for Devices and Radiological Health Food and Drug Administration Pharmaceutical sciences Medicine
14	Regulatory Background on Reclassification Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Federal Food Drug and Cosmetic Act Medical device Humanitarian Device Exemption Ventricular assist device Clinical trial Device file Title 21 of the Code of Federal Regulations Medicine Food and Drug Administration Health
15	INSTRUCTOR’S GUIDE REGULATORY PATHWAYS FOR PEDIATRIC MEDICAL DEVICES: MARKETING A PEDIATRIC MEDICAL DEVICE VIA A HUMANITARIAN DEVICE EXEMPTION INTRODUCTION Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Clinical research Technology Medical device Premarket approval Center for Devices and Radiological Health Adverse event Investigational Device Exemption Validation Medicine Food and Drug Administration Health
16	This document is scheduled to be published in the Federal Register on[removed]and available online at http://federalregister.gov/a[removed], and on FDsys.gov DEPARTMENT OF THE TREASURY Internal Revenue Service Add to Reading List Source URL: www.kslaw.com Language: English - Date: 2012-12-10 14:14:40 Technology Food law Pharmaceuticals policy Medical equipment Adulteration Federal Food Drug and Cosmetic Act Medical device Center for Biologics Evaluation and Research Humanitarian Device Exemption Medicine Food and Drug Administration Health
17	Office of Orphan Products Development Narrative Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmacology Pharmaceuticals policy Drug discovery Pharmaceutical industry Orphan drug Orphan Drug Act European Medicines Agency Humanitarian Device Exemption Medicine Pharmaceutical sciences Health
18	Overview of Pediatric Device Regulatory Considerations Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Health Pharmaceutical sciences Pharmacology Investigational Device Exemption Medical statistics Center for Devices and Radiological Health Humanitarian Device Exemption Premarket approval Food and Drug Administration Medicine Clinical research
19	[Federal Register: June 26, 1996 (Volume 61, Number[removed]Rules and Regulations] [Page[removed]From the Federal Register Online via GPO Access [wais.access.gpo.gov] [[Page[removed]______________________________ Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical sciences Pharmaceutical industry Pharmacology Pharmaceuticals policy Humanitarian Device Exemption Investigational Device Exemption Federal Food Drug and Cosmetic Act Premarket approval Food and Drug Administration Medicine Clinical research
20	Microsoft Word - Stryker Executive Summary FINAL 05Mar2012.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Food law Implants Humanitarian Device Exemption Institutional review board Medical device Stent Angioplasty Percutaneous Medicine Food and Drug Administration Interventional radiology

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