If you are of a certain age and are presented with a trio of items, we bet you sometimes add “Oh My” to the end of the list, as in Lions, and Tigers, and Bears-Oh My. Or, you think of other things that come in threes, such as the past and the present
de novo classification
In Important First, Claims Implicating Class II Medical Device that Received De Novo Classification Held Expressly Preempted
By Andrew Tauber on
This post is from the non-Reed Smith side of the Blog.
Breaking new ground, a court has for the first time held that the Medical Device Amendments to the Food, Drug, and Cosmetic Act expressly preempt product-liability claims implicating a Class II medical device brought to market through the “de novo” classification process. This is…