“Unpredictable, inefficient, and expensive regulatory processes put the U.S. at risk of losing its global leadership position in medtech innovation.”
In my former career in Biomedical Engineering, I would routinely replace DC fan motors (a high failure item) in Infant Incubators. I could purchase this replacement part from Radio Shack at that time for about $5. However, regulation forbade that, and this part therefore had to be purchased from an authorized medical device vendor.
From whom the same DC fan motor cost $225 each.
And that was in 1990.
Yes, I’d say a problem exists.





