06/03/2019
https://congress.gov...
"I hope moving forward that both agencies will work with the committee on the discussion draft circulated today."
"It is important that, as the committee considers this issue, we have a better understanding of the strengths and limitations of both FDA and CMS's authority in this area."
"We are also very concerned about this deemed-approved approach. It essentially says if we don't make it decision in time, it is approved."
"It does not make sense to regulate tests differently based on who develops them."