On the recordJuly 13, 2010
And I would also ask that once you have made the evaluations, let us not wait for a hearing to provide the Committee with your observations on the success or failure of those pilot programs.
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congress.govAnd I would also ask that once you have made the evaluations, let us not wait for a hearing to provide the Committee with your observations on the success or failure of those pilot programs.
Burr emphasizes timely communication on pilot program evaluations.
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I will tell you right now, Congress is going to require accountability in the new program.
I as an applicant should feel good about that. That tells me that there are less people working on application.
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 with so much more money?