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Center for Devices and Radiological Health
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#	Item
761	ODE Review Memorandum for Traditional and Abbreviated 510(k) Submissions Preparing a Review Memorandum When your review is complete, you should prepare a review memorandum. The review memorandum summarizes the informatio Add to Reading List Source URL: www.fda.gov Language: English Health Clinical pharmacology Pharmacology Therapeutics United States Public Health Service Center for Devices and Radiological Health Food and Drug Administration Pharmaceutical sciences Medicine
762	SMG[removed]FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY REGULATORY - GENERAL REDELEGATIONS OF AUTHORITY ISSUANCE OF REPORTS OF MINOR VIOLATIONS Effective Date: June 4, 2010 Add to Reading List Source URL: www.fda.gov Language: English Food and drink Center for Devices and Radiological Health Center for Food Safety and Applied Nutrition Center for Drug Evaluation and Research Title 21 of the Code of Federal Regulations Center for Biologics Evaluation and Research Center for Veterinary Medicine Federal Food Drug and Cosmetic Act Good Clinical Data Management Practice Food and Drug Administration Medicine Health
763	KINGSCSPALDING I 730 AVENUE, PENNSYLVANIA Add to Reading List Source URL: www.fda.gov Language: English - Date: 2001-01-10 06:51:00 Pharmaceutical sciences Iontophoresis Federal Food Drug and Cosmetic Act Premarket approval New Drug Application Investigational Device Exemption Medical device Center for Devices and Radiological Health Off-label use Food and Drug Administration Medicine Health
764	Supporting Statement - OMB No[removed] Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-11-26 14:34:41 Technology Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Medical device Title 21 of the Code of Federal Regulations Paperwork Reduction Act Criticism of the Food and Drug Administration Medicine Food and Drug Administration Health
765	ED institute, Incorporated 1400 Cumberiand Ave. West Lafayette, 1N[removed]Phone: [removed]November II,2005 Add to Reading List Source URL: www.fda.gov Language: English - Date: 2005-12-01 10:39:31 Pharmaceutical sciences Center for Devices and Radiological Health Medical device Food and Drug Administration Medicine Health
766	PLAN OF ACTION FOR IMPLEMENTATION OF 510(K) AND SCIENCE RECOMMENDATIONS In August 2010, the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH or the Center) Add to Reading List Source URL: www.fda.gov Language: English Clinical research Health Pharmaceutical industry Pharmacology Therapeutics Center for Devices and Radiological Health Medical device Adverse event Clinical trial Medicine Food and Drug Administration Pharmaceutical sciences
767	DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service $.#q-d Food and Drug Administration Center for Devices and Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-12-08 14:22:38 Food and Drug Administration Entertainment Laser lighting display Visual music Laser Variance Center for Devices and Radiological Health Title 21 of the Code of Federal Regulations Lasers and aviation safety Optics Statistics Medicine
768	Public Health Service DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Rockville MD 20857 Add to Reading List Source URL: www.fda.gov Language: English - Date: 2006-09-06 13:06:29 Technology Premarket approval Medical device Center for Devices and Radiological Health Conflict of interest Medicine Food and Drug Administration Health
769	BASF BASF Corporation December Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-02-06 07:12:30 Phthalates Medicine Endocrine disruptors Technology Bis(2-ethylhexyl) phthalate Polyvinyl chloride BASF Center for Devices and Radiological Health Plastic Plasticizers Chemistry Dielectrics
770	SYBIL NillEN GOLIIRICN Execuhve Director Co-founder Add to Reading List Source URL: www.fda.gov Language: English - Date: 2002-12-14 14:43:04 Medical technology Implants Breast surgery Breast implant Medical device Adverse event Mentor Center for Devices and Radiological Health Premarket approval Medicine Prosthetics Food and Drug Administration

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