In Law360, Life Sciences Attorneys Examine FDA’s Transition Plans for Medical Devices Under Emergency Use Authorizations and Enforcement Policies
In a Law360 article, life sciences regulatory & compliance partner Joshua Oyster, counsel Beth Weinman and associate Helen Ryan (all of Washington, D.C.) analyze two draft guidances regarding the U.S. Food and Drug Administration expectations for transitioning medical devices marketed under emergency use authorizations and Covid-19 related enforcement policies to full compliance with FDA regulatory requirements as the Agency looks past the current public health emergency and towards a return to normal operations.