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Substantial equivalence
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71	Page 1 of[removed]k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE A. 510(k) Number: k043474 Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2012-05-11 15:11:17 Accu-chek Biology Blood sugar Glucose test Test strip Physiology Glucose meter Blood tests Diabetes Medicine
72	GENETICALLY ENGINEERED CROPS Committee on Genetically Engineered Crops: Past Experience and Future Prospects—Public Meeting Monday, September 15, 1PM Add to Reading List Source URL: nas-sites.org Language: English - Date: 2014-09-12 14:07:36 Molecular biology Environment Biotechnology Agriculture Environmental issues Food and drink Genetically modified food Substantial equivalence Biology Genetic engineering Genetically modified organism
73	The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] 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 Good manufacturing practice Title 21 of the Code of Federal Regulations Investigational Device Exemption Title 21 CFR Part 11 Food and Drug Administration Medicine Health
74	Regulatory Public Laws Compliance &Education Policies Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Clinical pharmacology Therapeutics United States Public Health Service Substantial equivalence Tobacco Abbreviated New Drug Application Pharmaceutical sciences Clinical research Pharmacology
75	The New 510(k) Paradigm Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications Add to Reading List Source URL: www.fda.gov Language: English Health Investigational Device Exemption Premarket approval Medical device Federal Food Drug and Cosmetic Act Food and Drug Administration Modernization Act Center for Devices and Radiological Health Design controls Validation Food and Drug Administration Medicine Technology
76	HHS_FDA_CTP_Stached_White Add to Reading List Source URL: www.fda.gov Language: English Family Smoking Prevention and Tobacco Control Act Federal Food Drug and Cosmetic Act Center for Tobacco Products Substantial equivalence Tobacco Regulation of tobacco by the U.S. Food and Drug Administration New Drug Application Food and Drug Administration Health Medicine
77	Federal Ethics Committee on Non Human Biotechnology ECNH 12 December 2011 Ethical requirements for the experimental and commercial release of genetically modified plants Add to Reading List Source URL: www.ekah.admin.ch Language: English - Date: 2014-04-08 06:41:21 Emerging technologies Hazard analysis Biotechnology Genetically modified organism Genetically modified food Genetically modified plant Genetically modified maize Substantial equivalence Hazard Biology Genetic engineering Molecular biology
78	Note The material contained in this publication may be freely quoted or reprinted but acknowledgement is requested, together with a reference to the document number. A copy of the publication containing the quotation or Add to Reading List Source URL: www.biotrade.org Language: English - Date: 2014-06-16 04:40:20 Food and drink Food law Novel food Science Genetically modified organism European Union Food safety Substantial equivalence Specialty food ingredients Food science European Union law Biology
79	Gene Technology for Food Swiss Ethics Committee on Non-human Gene Technology (ECNH) Add to Reading List Source URL: www.ekah.admin.ch Language: English - Date: 2014-04-08 07:37:31 Molecular biology Emerging technologies Biotechnology Environmental issues Genetically modified organism Genetically modified food Genetically modified plant Substantial equivalence Monsanto Biology Genetic engineering Food and drink
80	TOXICOLOGY REQUIREMENTS FOR RISK ASSESSMENT OF GM FOOD AND FEED Harry A. Kuiper [removed] EuropaBio Workshop on the Risk Assessment Add to Reading List Source URL: www.europabio.org Language: English - Date: 2012-11-22 11:05:55 Environmental issues Food science Risk Probability Substantial equivalence Genetically modified organism Genetically modified food European Food Safety Authority EuropaBio Genetic engineering Biology Biotechnology

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