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But many devices require only a so-called 510(k) application that shows them to be of "substantial equivalence" to a device already on the market.
On the issue of testing new foodstuffs, whether modified or unmodified, they call for a more systematic approach to establishing "substantial equivalence"—the principle that GM and conventional foods are equally safe so long as they have the same composition.
Therefore, the name of the game for many healthcare startups is "substantial equivalence".
Affirmation of substantial equivalence is essential for safety assessment of the generated rice, particularly GM rice.
The principle of substantial equivalence is fundamental for assessment of genetically modified plants, justifying some explanation.
Food biosafety involves studies of substantial equivalence related to compositional analysis, toxicity and allergenicity.
These findings fundamentally challenge the basis for regulatory assumption of substantial equivalence between glyphosate-tolerant GM varieties and unmodified comparators.
None of these reviews mention herbicide residues or their potentially conflicting nature in relation to concept of substantial equivalence.
Such findings should fundamentally challenge regulatory assumption of substantial equivalence between glyphosate-tolerant varieties and their unmodified comparators.
The concept of substantial equivalence [23] is used by regulators and industry scientists to validate GM-crop quality.
The core principle of the process has been articulated as substantial equivalence, which is a comparative evaluation.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com