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Humanitarian Device Exemption
Results: 101

#	Item
81	HHS Letterhead ONLY Template Add to Reading List Source URL: www.fda.gov Language: English Health Prosthetics Emerging technologies Artificial organs Neuroprosthetics Visual prosthesis Pharmacovigilance Humanitarian Device Exemption Food and Drug Administration Pharmaceutical sciences Medicine Pharmacology
82	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Medical device Title 21 of the Code of Federal Regulations Humanitarian Device Exemption Parts Manufacturer Approval Investigational Device Exemption Food and Drug Administration Medicine Health
83	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Federal Food Drug and Cosmetic Act Medical device Center for Devices and Radiological Health Humanitarian Device Exemption Clinical trial Substantial equivalence Investigational Device Exemption Food and Drug Administration Medicine Health
84	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Medical device Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Title 21 of the Code of Federal Regulations Humanitarian Device Exemption Adverse event Clinical trial Food and Drug Administration Medicine Health
85	Guidance for Industry and Food and Drug Administration Staff Humanitarian Use Device (HUD) Designations Document issued on: January 24, 2013 Add to Reading List Source URL: www.fda.gov Language: English Technology Humanitarian Device Exemption Medical device Federal Food Drug and Cosmetic Act Premarket approval Rare disease Multiple myeloma Investigational Device Exemption Medicine Food and Drug Administration Health
86	Final Dispute Resolution Guidance Document - Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product Add to Reading List Source URL: www.fda.gov Language: English Prescription Drug User Fee Act Premarket approval Medical device Center for Devices and Radiological Health Abbreviated New Drug Application Investigational Device Exemption New Drug Application Humanitarian Device Exemption Center for Biologics Evaluation and Research Food and Drug Administration Medicine Health
87	(~ ...vrc•• ".. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Add to Reading List Source URL: www.fda.gov Language: English Health Premarket approval Investigational Device Exemption Federal Food Drug and Cosmetic Act Medical device Center for Devices and Radiological Health DeCODE genetics Humanitarian Device Exemption Food and Drug Administration Modernization Act Food and Drug Administration Medicine Technology
88	REPORT TO CONGRESS Premarket Approval of Pediatric Uses of Devices – FY[removed]Submitted Pursuant to Section 515A of the Federal Food, Drug, and Cosmetic Act Add to Reading List Source URL: www.fda.gov Language: English Federal Food Drug and Cosmetic Act Premarket approval Medical device Center for Devices and Radiological Health Humanitarian Device Exemption Patient safety Vagus nerve stimulation Medicine Food and Drug Administration Health
89	DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Silver Spring, MD[removed]March 17, 2009 Add to Reading List Source URL: www.fda.gov Language: English Technology Federal Food Drug and Cosmetic Act Premarket approval Center for Devices and Radiological Health Medical device Humanitarian Device Exemption Abbreviated New Drug Application Food and Drug Administration Medicine Health
90	Attachment E CDRH Final Guidance Cover Sheet Add to Reading List Source URL: www.fda.gov Language: English Technology Premarket approval Medical device Center for Devices and Radiological Health Investigational Device Exemption Federal Food Drug and Cosmetic Act Humanitarian Device Exemption Center for Biologics Evaluation and Research Food and Drug Administration Medicine Health

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