04/28/2021
https://congress.gov...
"I am also concerned about what the impact would be of giving this broad set of software a new definition and excluding it from the device definition."
"No, this doesn't codify our policy. It takes out from our authority the ability to assure the safety and effectiveness of devices that we currently regulate, including some high-risk devices."
"opening statement"
"But we think at the present time, this is just simply premature."