With new grass on the field, the 2019 baseball season is underway and optimism springs eternal. Here in Philadelphia, the Phillies have actually around the top of the NL east for the first time since, umm…., last year actually. But this year, having added possibly the best player and best catcher in the league,
Class II Medical Devices
Federal Court Rules That 510(k) Clearance Relates To Safety And Effectiveness
By Steven Boranian on
A myth that has regrettably gained some traction lately is that the FDA’s clearance of a medical device under the 510(k) substantial equivalence process is unrelated to safety and efficacy. One notably unfair manifestation of this myth is the entry of orders in limine in a number of recent medical device cases excluding evidence of…
Mostly Favorable MIL Rulings in IVC Filters Litigation
By Rachel B. Weil on