Are you curious why non-Pre-Market Approved devices are being so heavily discounted?
To view devices that are still compliant to the FDA’s ruling and the PMA, click here.
Q: Why are some distributors still selling these devices in the U.S.?
A: Great Question. The FDA has taken the position that AED devices that have NOT filed for the PMA approval should NOT be sold in the U.S. market.As a result, it is our opinion that anyone purchasing one of these devices is opening themselves up to liability. Continue reading DXE Medical PMA Series – Part 3: Where You Buy is Important