How to Select FDA Medical Device Product Code?

#1
In the past, selecting an appropriate FDA product code for our devices wasn't a problem: either we selected based on predicates, or there was a code that neatly described our product.

Now, however, I'm a bit undecided. We have a device for which there are multiple potential product codes that might be applied:
(1) One has a good physical description (matches our device), but the listed indications are only a subset of the conditions for which our device intended
(2) One has a not-so good physical description (does not quite match our device), but the indications and intended use are spot-on
(3) One is very general in the description and the indications (very vague description, very general intended use, and no specific conditions specified)

My question is: is there any (mandated) reason why you wouldn't always choose the most general description possible? Assuming implications such as classification, regulation, review panel, etc. are all the same, why would you choose a more specific product codes (options (1) & (2)), and not always just choose the most general (option (3))?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
I would go by the predicate. It makes things simpler and prevents added questions. The only cases I ran into where the device and the predicate didn't have the same procode were cases where the manufacturer actually intended the procode to be the same but the FDA decided that a different procode is more appropriate, during review.
 
#3
I would go by the predicate. It makes things simpler and prevents added questions. The only cases I ran into where the device and the predicate didn't have the same procode were cases where the manufacturer actually intended the procode to be the same but the FDA decided that a different procode is more appropriate, during review.
Thanks Ronen, I agree. ...but if it's the case of a Class I (or otherwise 510(k) exempt), and/or there is no known predicate, what approach to take?
It seems to me like it makes the most sense to always select the most general available product code that aligns with the device (option 3 in the original post).
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
Thanks Ronen, I agree. ...but if it's the case of a Class I (or otherwise 510(k) exempt), and/or there is no known predicate, what approach to take?
Even though it's not called "a predicate", for 510k-exempt devices you have to identify a sort-of "predicate" for the exemption to apply (see the regulations 8xx.9 sections). If you look up the exempt device's device listing you can find its procode.
Where there is no known predicate (or a device enabling the exemption) you will need to submit a De-Novo.
 


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