Today we’re talking about the third step in the five steps to market process – determining the right class and pathway for your device.
This is where a LOT of manufacturers trip up, heading merrily down the wrong submission path and thinking they’re in the clear, only to have the FDA stop them in their tracks.
It all comes down to the product code. Choose the right one, and you’re golden.
Choose the wrong one, and you’re off into the weeds on a very expensive adventure that will only extend your time to market.
Start with the FDA Product Code Classification Database, where you can find the following information:
- Device class
- Regulation # (including applicable controls)
- Recognized consensus standards (including requirements for design specs and validation testing)
- GMP exemptions (as applicable)
- And perhaps most importantly – the submission type.
Now you need to go back to the first lesson and the Intended Use and Indications for Use statements you created for your product, because these will steer you in the right direction, especially if your product falls within a common category.
Let’s use masks as our example:
A mask can have multiple FDA product codes and can be used in different environments depending on the Intended Use/Indications for Use.
Is it a comfort mask? Is it a surgical mask? Is it a surgical mask with antimicrobial agents? Is it a pediatric mask? Is it an N95?
Each type of mask has different submission and testing requirements, so you must be very clear on what your mask does and does not do when choosing the appropriate product code.
Your submission pathway can be as easy as a trip to the fridge for a snack or as difficult as a half-marathon – or an Ironman, if your product requires a PMA submission and it also plays a role in determining the amount and type of testing you need to do.
The fourth of the five steps to market is developing scientific evidence of your product’s safety and efficacy – and this can be where things get dicey.
The FDA requires the following (at a minimum):
- Pre-clinical testing (biocompatibility, sterilization and the like)
- Side-by-side bench testing
- Performance standard testing
- Animal testing (as applicable)
- Clinical testing
- Usability engineering testing
This is the usually where the R+D folks and the quality folks start infighting.
R+D feels as though their product is damn-near perfect and doesn’t need to be “proven” beyond what testing they may have done during development.
And documentation? We don’t need no stupid documentation.
Whereas the quality team – still bearing the scars from their last interaction with the FDA – knows what testing is needed and won’t even think of submitting a pre-sub until they get it.
If you’ve been following me you know my thoughts on the matter, and how expensive quality systems and documentation can be when developed in retrospect.
Read the regulations, know the requirements, and develop a testing plan that will meet ALL your regulatory needs.
Your C-suite may balk at the delay but your investors will (should) thank you for it.
Stay tuned for the final installment of the Startups Guide to The Five Steps to Market – coming soon!
