01/14/2009
https://www.congress.gov...
"I'm concerned that there's a proposal to regulate laboratory diagnostic tests as medical devices, and they're already regulated under CLIA."
"the review of the 510(k) products. It's become particularly burdensome, causing product approval delays and the frustration for the manufacturers, providers, and obviously the patients."
"I would just urge you to help improve upon the efforts to provide frequent, transparent communication with the companies."
"But in North Carolina, we have about 19,000 biopharmaceutical jobs in our State, and it is such an important part of our economy, and I want to make sure we do all we can to invest in this sector and ..."