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Center for Devices and Radiological Health
Results: 3105

#	Item
521	CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Guidance Development (Includes Special Controls Guidance Documents) CONTENTS PURPOSE Add to Reading List Source URL: www.fda.gov. Language: English Clinical research Documents Guidance document Publications Center for Devices and Radiological Health Food and Drug Administration Pharmaceutical sciences Medicine
522	FDA’s Home Use Medical Device Initiative Add to Reading List Source URL: www.fda.gov Language: English Health Medical informatics Pharmaceutical industry Therapeutics United States Public Health Service Center for Devices and Radiological Health Package insert Packaging and labeling Structured Product Labeling Food and Drug Administration Pharmaceutical sciences Medicine
523	U.S. Department of Health & Human Services U.S. Food and Drug Administration FDA Facts: Biomedical Innovation Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceutical sciences Medical device Center for Devices and Radiological Health Criticism of the Food and Drug Administration Reagan-Udall Foundation Food and Drug Administration Medicine Health
524	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
525	Overview of US FDA Regulatory Processes – Devices and Drugs and Applicability of Research Conducted Outside the US Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Pharmaceutical industry Medical statistics Clinical trial Center for Devices and Radiological Health ERT Research Clinical research Food and Drug Administration
526	Attachment E CDRH Final Guidance Cover Sheet Add to Reading List Source URL: www.fda.gov. Language: English Premarket approval Center for Devices and Radiological Health Investigational Device Exemption Medical device Center for Biologics Evaluation and Research Federal Food Drug and Cosmetic Act New Drug Application Investigational New Drug Title 21 CFR Part 11 Food and Drug Administration Medicine Health
527	CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Standard Operating Procedure for “Notice to Industry” Letters Add to Reading List Source URL: www.fda.gov. Language: English Health Premarket approval Center for Devices and Radiological Health Medical device Guidance document Unique Device Identification Medicine Food and Drug Administration Technology
528	Building a National Infrastructure for Medical Device Surveillance Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Center for Devices and Radiological Health Premarket approval Medical device Federal Food Drug and Cosmetic Act Clinical trial Investigational Device Exemption Food and Drug Administration Medicine Health
529	Patient Preference Workshop Incorporating patient preference information into the Medical Device Total Product Life Cycle (TPLC) regulatory paradigm September 19, 2013 Add to Reading List Source URL: www.fda.gov Language: English Technology Pharmacology Medical technology Medical equipment Clinical research Medical device Center for Devices and Radiological Health Clinical trial Patient safety organization Medicine Health Food and Drug Administration
530	[removed]Product Manager Add to Reading List Source URL: www.fda.gov. Language: English Health Center for Veterinary Medicine Abbreviated New Drug Application Ombudsman Center for Devices and Radiological Health Food and Drug Administration Pharmaceutical sciences Clinical research

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