Substantial equivalence is a useful tool

Beyond Substantial Equivalence : Ethical Equivalence

The concept of substantial equivalence, introduced for the risk assessment of genetically modified (GM) food, is a reducing concept because it ignores the context in which these products have been produced and brought to the consumer at the end of the food chain. Food quality cannot be restricted to mere substance and food acts on human beings not only at the level of nutrition but also through...

Evaluation of Substantial Equivalence of salinity-resistant transgenic potato

Transgenic plants and their products are being developed day by day due to their improved characteristics, and it is necessary to evaluate the safety of these plants before releasing them. Hence, the importance of the issue of biosafety of transgenic plants and the use of their products has led the regulatory agencies to create some laws called substantial equivalence. based on that, the essent...

Beyond 'substantial Equivalence'

Whenever official approval for the introduction of genetically modified (GM) foods has been given in Europe or the United States, regulatory committees have invoked the concept of 'substantial equivalence'. This means that if a GM food can be characterized as substantially equivalent to its 'natural' antecedent, it can be assumed to pose no new health risks and hence to be acceptable for commer...

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

A. 510(k) Number: k093974 B. Purpose for Submission: New Device C. Measurand: Factor II (FII) (Prothrombin) Factor V (FV) Leiden 5, 10 methylenetetrahydrofolate reductase (MTHFR) D. Type of Test: Qualitative genotyping test for single nucleotide polymorphism detection E. Applicant: Osmetech Molecular Diagnostics F. Proprietary and Established Names: eSensor® Thrombophilia Risk Test eSensor® FII...