Day: November 9, 2017

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 such as restaurants, buffet style … Read more

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 and then suspended a decision to strictly regulate genetic … Read more