It's getting harder and harder to bring lifesaving devices to the marketplace in the United States because of a lack of consistency, predictability and transparency in the Food and Drug Administration's premarket review processes.
Paulsen highlights challenges in FDA processes affecting medical device innovation.
Share & report
More from Erik Paulsen
One company in Minnesota, Acorn Cardiovascular, recently had to close its doors due to such inconsistencies.
If you do make changes in one area, it impacts quite a few different areas in other sections of the Code.
The legislation also includes an important exemption for businesses that do not exceed $500,000 in remote sales.
This is a policy that is actually being very harmful to achieving this goal, as our witnesses have already pointed out.
Other voices in this conversation
