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Re: [IP] FDA notice on H-TRONplus V100 Infusion Pump

Patrick G. Jobe <email @ redacted> wrote:

> Geez. The FDA (our watchdog) is really on the ball. What is this 5+ months 
> to acknowledge a letter has been sent out!!!!!

The FDA is under almost constant negative scrutiny by congressional conservatives (and, currently, the White House) who do not want the FDA or any other federal agency to cause problems for businesses.  As a result, the FDA is perpetually under funded and under staffed.  If you want to see better performance of issues like this, write to your Representative and Senators and ask them to increase the budget and appropriations for the FDA.

To get a good idea of how all of this works, read David Kessler's book, "A Question of Intent".  While the book is about the FDA's dealings with the tobacco industry, it does illustrate how congressional mandate, funding, and the regulatory process works.

Jim Handsfield
mailto:email @ redacted

The opinions expressed are mine and do not necessarily reflect those of my wife who runs this house and makes more important decisions than I do.
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