This is obviously a no-no. I'm looking at submitting a 510(k) application soon and have got used to seeing the term "FDA Approval" in marketing and advertising material.
I've read the thread here on Reference to FDA on label or labelling and also the FDA's guidance document on labeling (470.pdf) and CFR 807.97.
So what's the alternative to "FDA Approved" for use in advertising and marketing?
"Cleared for sale by the FDA"
"Cleared for sale in the U.S."
"Legally marketable"
"FDA doesn't object to me selling this"
I've read the thread here on Reference to FDA on label or labelling and also the FDA's guidance document on labeling (470.pdf) and CFR 807.97.
So what's the alternative to "FDA Approved" for use in advertising and marketing?
"Cleared for sale by the FDA"
"Cleared for sale in the U.S."
"Legally marketable"
"FDA doesn't object to me selling this"


