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Humanitarian Device Exemption
Results: 101

#	Item
61	Assessing User Fees; PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions Bundling Multiple Devices in a Single Application and Fees for Combinations PRoducts; Guidance for Industry and F Add to Reading List Source URL: www.fda.gov Language: English Technology Investigational Device Exemption Premarket approval Federal Food Drug and Cosmetic Act Medical device Center for Devices and Radiological Health Title 21 of the Code of Federal Regulations Clinical trial Humanitarian Device Exemption Food and Drug Administration Medicine Health
62	Introduction and Regulatory Reference Sheet Dental Products Panel July 18, 2013 On July 18, 2013, the Dental Products Panel (the panel) will discuss and make recommendations regarding the classification of blade-form end Add to Reading List Source URL: www.fda.gov Language: English Premarket approval Medical device Federal Food Drug and Cosmetic Act Humanitarian Device Exemption Dental implant Clinical trial Investigational Device Exemption Breast implant Medicine Food and Drug Administration Health
63	Federal Register / Vol. 63, No[removed]Tuesday, November 3, [removed]Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 814 [Docket No. 98N–0171] Add to Reading List Source URL: www.fda.gov Language: English Food law Technology Pharmaceuticals policy Pharmacology Clinical research Food and Drug Administration Modernization Act Federal Food Drug and Cosmetic Act Humanitarian Device Exemption Premarket approval Food and Drug Administration Medicine Health
64	Microsoft Word[removed]CFR[removed]docx Add to Reading List Source URL: www.fda.gov Language: English Health Medical device Humanitarian Device Exemption Title 21 of the Code of Federal Regulations Premarket approval Medicine Food and Drug Administration Technology
65	Regulatory Background on Reclassification Add to Reading List Source URL: www.fda.gov Language: English Premarket approval Federal Food Drug and Cosmetic Act Medical device Ventricular assist device Humanitarian Device Exemption Clinical trial Investigational Device Exemption Center for Devices and Radiological Health Medicine Food and Drug Administration Health
66	Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff Add to Reading List Source URL: www.fda.gov Language: English Technology Humanitarian Device Exemption Medical device Investigational Device Exemption Federal Food Drug and Cosmetic Act Premarket approval Title 21 of the Code of Federal Regulations Center for Biologics Evaluation and Research Medicine Food and Drug Administration Health
67	Microsoft Word[removed]CFR[removed]docx Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Clinical pharmacology Humanitarian Device Exemption Medical device Center for Devices and Radiological Health Food and Drug Administration Medicine Health
68	Attachment B CDRH Draft Guidance Cover Sheet Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Premarket approval Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health ClinicalTrials.gov Humanitarian Device Exemption Title 21 of the Code of Federal Regulations Clinical trial Food and Drug Administration Medicine Health
69	Pediatric Devices for Rare Diseases Clinical Trials Issues Panel Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Clinical research Pharmaceutical industry Drug safety Premarket approval Humanitarian Device Exemption Medical device Center for Devices and Radiological Health Food and Drug Administration Medicine Health
70	HUD Overview Eric Chen, MS Director, Humanitarian Use Devices Program OOPD, FDA Advancing Medical Devices for Pediatric Patients with Rare Diseases Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Medical statistics Statistics Pharmaceuticals policy Humanitarian Device Exemption Pharmacology Prevalence Rare disease Incidence Epidemiology Medicine Health

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