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Humanitarian Device Exemption
Results: 101

#	Item
21	510k Approval - National Donor Deferral Registry (NDDR)1.0, American Blood Resources Association Add to Reading List Source URL: www.fda.gov Language: English Technology Federal Food Drug and Cosmetic Act Premarket approval Medical device Humanitarian Device Exemption Investigational Device Exemption Food and Drug Administration Medicine Health
22	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 Clinical trial Validation Title 21 of the Code of Federal Regulations Investigational Device Exemption Food and Drug Administration Medicine Health
23	Regulatory Background on Reclassification Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Medical device Federal Food Drug and Cosmetic Act Humanitarian Device Exemption Clinical trial Investigational Device Exemption Center for Devices and Radiological Health Food and Drug Administration Medicine Health
24	Microsoft Word[removed]CFR[removed]docx Add to Reading List Source URL: www.fda.gov Language: English Health Technology Clinical research Drug safety Design of experiments Institutional review board Humanitarian Device Exemption Premarket approval Medical device Medicine Pharmacology Food and Drug Administration
25	Contains Nonbinding Recommendations Unique Device Identifier System: Frequently Asked Questions, Vol. 1 Guidance for Industry and Food and Drug Administration Staff Add to Reading List Source URL: www.hibcc.org Language: English - Date: 2014-08-20 14:30:04 Health Unique Device Identification Medical device Federal Food Drug and Cosmetic Act Radio-frequency identification Quality management system Center for Devices and Radiological Health Humanitarian Device Exemption Food and Drug Administration Medicine Technology
26	Report to Congress - Barriers to the Availability of Medical Devices Intended for the Treatment or Diagnosis of Diseases and Conditions that Affect Children Add to Reading List Source URL: www.fda.gov Language: English Technology Federal Food Drug and Cosmetic Act Medical device Premarket approval Center for Devices and Radiological Health Humanitarian Device Exemption Clinical trial Investigational Device Exemption Food and Drug Administration Medicine Health
27	Contains Nonbinding Recommendations Unique Device Identifier System: Frequently Asked Questions, Vol. 1 Guidance for Industry and Food and Drug Administration Staff Add to Reading List Source URL: www.gs1.org Language: English - Date: 2014-08-21 03:38:48 Health Unique Device Identification Medical device Federal Food Drug and Cosmetic Act Radio-frequency identification Quality management system Center for Devices and Radiological Health Humanitarian Device Exemption Food and Drug Administration Medicine Technology
28	Microsoft Word - SOP for Humanitarian Use Device.doc Add to Reading List Source URL: www.southalabama.edu Language: English - Date: 2008-11-12 11:15:12 Clinical research Research Pharmaceutical industry Food and Drug Administration Medical ethics Humanitarian Device Exemption Expanded access Adverse event Off-label use Pharmacology Medicine Pharmaceutical sciences
29	GAO Logo (Black_white-w_stroke)cover Add to Reading List Source URL: www.gao.gov Language: English - Date: 2011-09-29 19:10:40 Technology Premarket approval Medical device Federal Food Drug and Cosmetic Act Humanitarian Device Exemption Product recall Class I recall Center for Devices and Radiological Health Food and Drug Administration Medicine Health
30	DEPARTMENT OF HEALm &. HUMAN SERVICES Public HealthService Food and Drug Administration 9200 Corporate Boulevard Add to Reading List Source URL: www.fda.gov Language: English - Date: 2004-11-15 09:59:07 Health Clinical research Pharmaceutical industry Pharmacology Investigational Device Exemption Medical statistics Premarket approval Humanitarian Device Exemption Medical device Food and Drug Administration Medicine Pharmaceutical sciences

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