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Center for Devices and Radiological Health
Results: 3105

#	Item
671	--&A/yFA DEPARTMENT OF l3lULXH & HUMAN SERVICES Public Health Service Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-10 17:35:10 Food and Drug Administration Entertainment Laser lighting display Visual music Laser Center for Devices and Radiological Health Variance Title 21 of the Code of Federal Regulations Lasers and aviation safety Optics Statistics Medicine
672	The Changing World of Medical Devices Add to Reading List Source URL: www.fda.gov. Language: English Technology Federal Food Drug and Cosmetic Act Premarket approval Medical device Fee Credit card Center for Devices and Radiological Health Medicine Food and Drug Administration Health
673	The Clinical Investigator: Responsibilities in Medical Device Clinical Trials Presented by Catherine Parker, RN Consumer Safety Officer Division of Bioresearch Monitoring Add to Reading List Source URL: www.fda.gov. Language: English Research Health Food and Drug Administration Design of experiments Pharmaceutical industry Clinical trial Institutional review board Clinical investigator Center for Devices and Radiological Health Medicine Pharmacology Clinical research
674	The Least Burdensome Provisions of the FDA Modernization Act of 1997 Concept and Principles A Document Prepared by Representatives of The Least Burdensome Industry Task Force and FDA Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Food and Drug Administration Modernization Act Federal Food Drug and Cosmetic Act Premarket approval Center for Devices and Radiological Health Substantial equivalence Food and Drug Administration Medicine Health
675	APPENDIX E DEVELOPMENT OF COSTS FOR THE PROCESS FOR THE REVIEW OF MEDICAL DEVICE APPLICATIONS GENERAL METHODOLOGY The costs associated with the process for the review of medical device applications are based on Add to Reading List Source URL: www.fda.gov Language: English Center for Devices and Radiological Health Center for Biologics Evaluation and Research Prescription Drug User Fee Act Medical device Indirect costs Office of Regulatory Affairs Cost Premarket approval Food and Drug Administration Medicine Health
676	Roster of the FDA/CDRH Gastroenterology and Urology Devices Panel December 2, 2010 CHAIRPERSON Karen L. Woods, M.D. Clinical Associate Professor of Medicine Baylor College of Medicine, Houston, TX Add to Reading List Source URL: www.fda.gov Language: English Urologists Surgeons Medicine Center for Devices and Radiological Health Food and Drug Administration
677	Electronic Medical Device Reporting (eMDR) Eugene Reilly Public Health Analyst [removed] Add to Reading List Source URL: www.fda.gov. Language: English Medical equipment Center for Devices and Radiological Health Medical device Eye movement desensitization and reprocessing Medicine Health Food and Drug Administration
678	TOTAL COSTS OF THE PROCESS FOR THE REVIEW OF MEDICAL DEVICE APPLICATIONS Table 7 shows the costs for the review of medical device applications during the past two fiscal years by FDA organizational component. It depicts Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Center for Devices and Radiological Health Medical device Center for Biologics Evaluation and Research Prescription Drug User Fee Act Medicine Food and Drug Administration Health
679	Draft Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Full Field Digital Mammography System DRAFT GUIDANCE Add to Reading List Source URL: www.fda.gov Language: English Health Premarket approval Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Title 21 of the Code of Federal Regulations Design controls Mammography Quality management system Medical device Medicine Food and Drug Administration Medical technology
680	Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions Add to Reading List Source URL: www.fda.gov Language: English Health informatics Food law Medical physics Radiology Medical imaging Computer-aided diagnosis Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Magnetic resonance imaging Medicine Health Food and Drug Administration

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