Mark DuVal quoted in FDAWebview article: "When FDA Goes To Bat For One Company Against Another"

  • Published on: April 17, 2017
  • Category: Firm News

DuVal & Associates President and CEO Mark DuVal was quoted in an FDAWebview analysis by Jim Dickinson which highlights the strength and quality of the firm's relationship with FDA:

That’s not the way DuVal sees it. Sealfon’s view “certainly ascribes more influence and power than we have with the agency,” he wrote in commenting on a draft of this article...

When FDA Goes to Bat for One Company Against Another Analysis by Jim Dickinson - April 17th, 2017 View source

The FDA is a very data driven, fair-minded, consumer-safety driven agency. Anything we brought to their attention was independently verified by dedicated and astute agency personnel. I don’t think anyone for a minute believes the FDA would conspire with our firm or any other firm. We have good and respectful relationships there, but often our job is to challenge their thinking and advocate for our client. It helps when the law and regulations are on our side...

When FDA Goes to Bat for One Company Against Another Analysis by Jim Dickinson - April 17th, 2017 View source

There is way more to the RMS story than is told in your first draft. Our FDA complaint speaks for itself. The simple facts are these. There are three issues RMS has faced with FDA. Two issues relate to modifications to their device which were not submitted to FDA for review. FDA requires that when a medical device is modified by a company, the company has two options: to file a new 510(k), or do an internal letter-to-file that can be seen by an investigator upon a routine inspection. If the change is a) "major change" to the intended use, or b) a change that "significantly affects safety or effectiveness," then the company must submit a new 510(k) to FDA to permit a review to determine if the modified device is still safe and effective with those changes.

"Our point was simple. RMS is marketing a new generation device for which it did not receive FDA clearance. The third issue relates to FDA’s inspection of their firm for which RMS received some serious quality observations...

When FDA Goes to Bat for One Company Against Another Analysis by Jim Dickinson - April 17th, 2017 View source
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