“We support FDA’s efforts to update the medical device review regime to better accommodate digital health devices and believe that it is an important step in ensuring that America remains an innovative, cutting-edge producer of medical devices. However, it is essential that changes to FDA’s regulatory framework are done in compliance with the current statutory framework and do not compromise public safety.” Sens. Elizabeth Warren (D-Mass.), Tina Smith (D-Minn.) and Patty Murray (D-Wash.) wrote in a letter dated Oct. 10 to FDA Commissioner Scott Gottlieb.
Their letter requests a response from Gottlieb by Nov. 9. FDA plans to respond directly to the senators, said agency spokesperson Stephanie Caccomo.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.