Kay Hagan actually said...

"One complaint that I continue to hear from constituent companies is that the FDA's medical device review process is unpredictable and inconsistent."

"Moreover, the agency may not ask for scientific evidence, greater than the 'least burdensome,' to answer the question."

"I think that's critical."

"If I reference the IOM report again here, in the United States, use of clinical data in the regulatory review process is defined by the enabling legislation, regulations and FDA's implementation of th..."