Is it true that Medicare (and perhaps other third party payers) will only pay for products which are FDA registered? How do I find out if a DMEPOS product is FDA registered?
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That is a doozy of a question and I may run out of room here if I were to provide a thorough answer on how this happens.
To be brief, lets start off with a minor correction. A product needs to be listed in the FDA database. The facility which maufactures the oduct is what is registered.
Depending on what class and device type and history of other similar devices on the market the product may or may not require something called a 510K or pre market approval process (PMA).
Most DME devices used by DPM's will be 510K or PMA exempt, simply because there is a predicate device on the market. Think of how many compression stockings, diabetic shoes, cam boots, etc. are already on the market. That registration of the company and listing of the product does not come free. For the calendar year 2025, the FDA listing costs $9,200 that's up from $7600 in 2024.
Once they are listed on the FDA website then the company can think about obtainng PDAC (that's the Medicare agency which validates products). The PDAC will not even look at a PDAC validation application without an up to date FDA listing.
The question one must ask themselves is are you liable for dispensing a product which was not listed by the FDA?
That's a great legal question and I would punt the legality of that to the attorneys out there. My non legal mind might at first think, well that's not my responsibility, but on the other hand can you imagine how you would look to a jury if a plaintiffs attorney pointed out to a jury that their client was injured because you provided them with a defective product that was not FDA listed or registered? Momma Mia!!!
The FDA has a website where one can check the current listings/registrations located at:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
These are kept fairly current.
Also beware that some products listed on PDAC were validated years ago and the mfg may have chosen to not renew their FDA registration. The PDAC does not audit those files regularly. Thus the only way to check the registration is via the FDA website.