Life sciences growth · Video
FDA Cleared vs Approved: Use the Right Words
VayoMed Team ·
About this video
Episode 03 reviews FDA pathway wording and the evidence a buyer can check beside a regulatory claim. It covers decision numbers, distributor pages and review by regulatory affairs.
Full transcript
Is your 510(k) device FDA approved? No. It's FDA cleared, and buyers who check will notice the difference.
From 2015 to 2025, FDA recorded about 33,000 510(k) clearances, 343 De Novo grants, and only 386 original approvals. Approval is about one decision in a hundred.
So match each claim to its pathway. A 510(k) device is cleared. A De Novo device is granted. Only a PMA device is approved.
And registration is not approval either. Of 151 press releases that used the phrase FDA registered, 142 cited no premarket decision at all.
Three fixes. One: print the K, De Novo or PMA number beside every claim. Two: correct press releases and distributor pages first. Three: let regulatory affairs sign off every status phrase.
Say exactly what FDA decided. Nothing more.