Merit Medical Systems Inc., a South Jordan-based company that makes and markets disposable medical devices, said it has received a warning letter from the U.S. Food and Drug Administration over changes it has made to one of its products that is manufactured in Ireland.
The company said the FDA raised questions about the coating the company uses on its "Merit Laureate Guidewire," which is designed to help physicians place other medical devices, such as catheters, in blood vessels.
 |
Join the Discussion |
 |
Post a Comment |
Merit manufactures the product in its plant in Galway and imports it to the United States.
"We made what we believed were minor changes to the product over time, changes that we did not believe required us to get additional approval from the FDA," said Fred Lampropoulos, Merit’s chairman and CEO.
The FDA, though, disagreed and issued the warning letter. The FDA’s website explains that such notices are one of the agency’s "principal means of achieving prompt voluntary compliance" with its regulations.
Lampropoulos, who was contacted while traveling in the Netherlands, said Merit intends to work with the FDA to address its concerns within the allotted 15-day response period. He said Merit already has started to work toward resolving the issues raised in the warning letter.
"The FDA’s warning letter only applies to that one product, which represents less than one percent of our total revenues for 2011," he said.
He added that Merit’s Irish facility remains fully functional for all other products.
Copyright 2012 The Salt Lake Tribune. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
