Three Democratic senators representing major high tech and medtech hubs in the United States are questioning the statutory basis of FDA’s new pilot program for digital health product precertification.
“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.
The post Senators question basis for FDA’s digital health pre-cert pilot appeared first on MassDevice.