As the cannabis industry continues to grow and expand at a rapid pace, successful operators could become the targets of labeling class actions that have plagued the traditional food and beverage industry for decades,...more
In response to widespread shortages of protective masks, face shields and other medical devices and device components (e.g., ventilators and ventilator parts) in light of COVID-19, some colleges and universities with the...more
On November 26, 2018, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of FDA’s Center for Devices and Radiological Health (CDRH), issued an extensive...more
In recognition of the increasing prevalence of connected medical devices, and the potential cybersecurity vulnerability of the same, the U.S. Food and Drug Administration (FDA or the Agency) issued on October 18, 2018 a draft...more
Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) took a number of steps to “advance medical device innovation and help patients gain faster access to beneficial technologies,” as characterized by FDA...more
On March 13, 2017, the U.S. Food and Drug Administration (FDA or the Agency) identified a list of 1,003 types of Class II medical devices that, when finalized, will be exempt from the Agency’s premarket notification (i.e.,...more