Richard Burr: “I think that we have to hit this fairly accurately from a standpoint of the size of these institutions.”

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

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?

The faster, more predictable, and more accountable the programs are, the more patients stand to benefit from lifesaving, innovative drugs and devices.

There is no Member that has defended the FDA more than this one and there is no Member in Congress that has tried to fix areas when they are broken than this one.