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))?
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))?