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Newsletter - November 9, 2017
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FDA Exempts Most DTC Genetics Tests From 510k

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In an announcement this week, FDA classified most predictive genetic tests to be 510k-exempt. This is a remarkable about-turn for the Agency who till recently viewed genetic tests to be high risk devices that need 510k or even PMA approval. Last year only FDA first announced... Read More

Menu Labeling Simplified by FDA 

FDA works hard to create all its Guidance documents but occasionally you come across a master piece, an exceptional Guidance Doc that meets all one could wish for, or at least tries to give everyone everything. In one such Guidance document released this week, FDA presented how diverse food providers... Read More

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