Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products

Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products





Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products



The FDA is committed to ensuring that we have the right policies and processes in place to fulfill our public health mission. This includes providing clear rules to medical product manufacturers about fundamental issues such as how the FDA will determine the intended use of a medical product. We heard concerns that the FDA’s final rule to amend the agency’s existing intended use regulations – put forward a year ago in January 2017 – wasn’t clear, and we’re committed to addressing this important issue. Continue reading...