How do you go about choosing the right predicate device?
Say you’ve developed a new tree-borne fruit and you need to know how to submit it to the Fruit Deciding Agency for approval.
In looking at the chart below, you’d probably choose A or B. Your fruit has a smooth and shiny green skin and grows on a similar type of tree.
Easy peasy, right? C was not even considered because we all know you can’t compare apples to oranges. Or can you?
What if a peek below the skin of your product exposes a juicy, orange, pulp-like fruit?
Now what? It depends.
What is the intended use of your new fruit? Pies, jellies, snacking? Or is it really only suited for making juice? Are you submitting only to the Fruit Deciding Agency, or do you also want to get your Certified Edible mark? Have you completed biocompatibility testing to prove your new fruit isn’t poisonous?
If your fruit/product falls somewhere between two others already on the market, you can select a primary predicate (A – because it has the most similarities) and a secondary reference predicate (C, thanks to the orange and pulpy interior).
This will allow you to go the traditional 510(k) submission route to selling at the farmer’s market because you have demonstrated to the FDA that your fruit has substantial equivalence with other legally-marketed fruits.
Deciding what to call it is another matter altogether. Aprange? Orapple? Green Orange? Navel Apple? The possibilites are endless. 😜
When you are dealing with an actual medical device, choosing the right predicate device requires much more thought, and careful consideration of many factors. But you may still be able to compare your new apple to a competitor’s legally-marketed orange – if you know what you are doing.
Link to the original post:Â https://www.linkedin.com/posts/michellelottraqa_medicaldevices-regulatory-quality-activity-6764609819518238720-VYmG
If you want to learn more about choosing the right FDA pathway for your product, my website is chock-full of information:Â https://leanraqa.com/
