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