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The top documents tagged [substantial equivalence]

G2 Innovations Inc. The Wright Hand ® Development and Commercialization of a Novel Hand Prosthesis Raquel Lopez, Muris Mujagic, Michael Olsen, Albert Vette,
G2 Innovations Inc. The Wright Hand ® Development and Commercialization of a Novel Hand Prosthesis Raquel Lopez, Muris Mujagic, Michael Olsen, Albert Vette,
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"Determining the Regulatory Pathway to Market" Classification Heather S. Rosecrans Director, 510(k) Staff Office of Device Evaluation Center for Devices
"Determining the Regulatory Pathway to Market" Classification Heather S. Rosecrans Director, 510(k) Staff Office of Device Evaluation Center for Devices
219 views
GU Advisory Panel Meeting GU Advisory Panel Meeting Nocturnal Home Hemodialysis Carolyn Y. Neuland, Ph.D. Chief, Gastroenterology and Renal Devices Branch
GU Advisory Panel Meeting GU Advisory Panel Meeting Nocturnal Home Hemodialysis Carolyn Y. Neuland, Ph.D. Chief, Gastroenterology and Renal Devices Branch
222 views
The Pusztais’ guide to GMOs and regulation Susan Bardocz and Arpad Pusztai
The Pusztais’ guide to GMOs and regulation Susan Bardocz and Arpad Pusztai
226 views
Basic Concepts BMT. Instrumentation design and development is a creative process involving an idea and then taking it to the implementation level (prototype
Basic Concepts BMT. Instrumentation design and development is a creative process involving an idea and then taking it to the implementation level (prototype
212 views
Bayesian Statistics at the FDA: The Pioneering Experience with Medical Devices Greg Campbell, Ph.D. Director, Division of Biostatistics Center for Devices
Bayesian Statistics at the FDA: The Pioneering Experience with Medical Devices Greg Campbell, Ph.D. Director, Division of Biostatistics Center for Devices
224 views
Safety and Regulation in Agricultural Biotechnology MUPGRET Workshop
Safety and Regulation in Agricultural Biotechnology MUPGRET Workshop
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Risk assessment practice in the context of legislation and guidelines Armin Spök Inter-University Research Centre for Technology, Work and Culture (IFF/IFZ)
Risk assessment practice in the context of legislation and guidelines Armin Spök Inter-University Research Centre for Technology, Work and Culture (IFF/IFZ)
214 views
Reuse of Single Use Devices CDRH/CBER MDUFMA Stakeholder Meeting Presented by: Barbara Zimmerman
Reuse of Single Use Devices CDRH/CBER MDUFMA Stakeholder Meeting Presented by: Barbara Zimmerman
219 views
A Consumer Perspective on Biotech Foods Gregory Jaffe Director, Biotechnology Project Center for Science in the Public Interest October 7, 2004
A Consumer Perspective on Biotech Foods Gregory Jaffe Director, Biotechnology Project Center for Science in the Public Interest October 7, 2004
218 views
The Safety of Food and Feed Derived from GE Crops
The Safety of Food and Feed Derived from GE Crops
223 views
AquaAdvantage Salmon Lisa Danielson. Outline Introduction Explanations Significance Research Question Methodology My approach Literature Review Problems
AquaAdvantage Salmon Lisa Danielson. Outline Introduction Explanations Significance Research Question Methodology My approach Literature Review Problems
222 views