Actually, the wings are on fire – ENVI vote result worst of all worlds

Two weeks ago I made a prediction on some worst case scenarios that could come out of ENVI today. That turned out to be pretty accurate given what I know at this moment about the outcome of ENVI’s vote. ENVI did today what only happens in your worst nightmare: take several compromises and mash that into a compromise of compromises that cannot possibly work effectively. PMA-esque ENVI decided to propose a PMA-esque procedure involving special notified bodies that even lawyers have difficulty understand [...] « Read the rest of this article on medicaldeviceslegal »