03/27/2017
https://congress.gov...
"As we customize medicine, it is imperative that the Food and Drug Administration have the ability to thoroughly examine these devices in a timely manner."
"Unfortunately, his signature legislation coupled with the Food and Drug Administration's confusing and somewhat disjointed approval process has instead encouraged the off-shoring of business and broug..."
"However, the long and arduous process that is frequently ambiguous adversely affects everyone, including those patients who desperately need the device."
"It is a shame that this committee has been stonewalled."