05/06/2014
https://congress.gov...
"will the proposed cut jeopardize the number of review staff that FDA is able to employ at the center? Yes or no."
"one of the complaints that my office consistently receives is that medical device approval process has a certain inconsistency from reviewers at the Center for Devices and Radiological Health."
"Now, there are some areas of improvement in the current medical device approval process but I would ask my colleagues here, does anybody remember the Dalkon Shield?"
"So is there anybody around here that wants to return to what President Ford called the horse and buggy days of device regulation?"