Tag: FDA Warnings

WASHINGTON – A consumer warning from the Food and Drug Administration urging against using oxygen concentrators without a prescription has resulted in some interesting calls for HME providers.  Portable Oxygen Solutions, an online provider of POCs and accessories, saw an uptick last March in people wanting to buy POCs for themselves or family members, says Todd Flesch, co-founder of the Charlotte, N.C.-based company.  “On calls, when we explained...

CHARLOTTE, N.C. - Add Prodigy Diabetes Care to the list of HME manufacturers that has received warning letters from the U.S. Food and Drug Administration (FDA).In a letter dated Feb. 22 but only posted to the agency's website July 11, the FDA faults Prodigy with, among other things, “failure to report to the FDA no later than 30 days after the day that your firm received or otherwise became aware of information that a device that it markets may have caused or contributed to a death or serious...