Assurance of no additional spending on the project.
06/16/2009
https://www.congress.gov...
The FDA failed to do its job, plain and simple.
I went through a litany in my opening statements of the deficiencies in what FDA committed to and what they missed.
I will continue to ask you for a plan until we get one, and I will continue to be a roadblock for those who believe that...
Why did FDA agree, and why did the industry agree to longer review times of 128 days on 510(k)'s and provide the agency ...