Richard Burr: “Do I have your assurance that you are going to share it with the Committee?”

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?

I hope to receive that response soon.

What does it mean for a small company when FDA misses these goals, and what does it mean to patients?

The FDA failed to do its job, plain and simple.