Choosing the right FDA pathway for your product is not easy and can be fraught with regulatory landmines. But by asking yourself a few simple questions you can avoid those pitfalls and develop a successful FDA submission strategy.
Do you have a product, an accessory, or a component? Manufacturers often don’t know how the FDA would classify their product, or whether it would actually be classified it as an accessory or a component. And even when the classification is clear, the regulatory pathway may not be.
Do you know the difference between FDA clearance, approval and authorization? A lot of medical device manufacturers don’t, so the terms are often misused and misinterpreted.
I met with a group of medical device manufacturers in the fall of 2020. Not surprisingly, they had LOTS of questions specific to ventilators and ventilator accessories and components.
We started by clarifying the differences between a product, accessory and component. Then we discussed the differences between FDA clearance, authorization and approval. Only then were we able to move on to choosing the right FDA pathway for their products.
The standard FDA submission process remains unchanged, but the EUA has introduced a host of other regulations and requirements. We did not get into that in this presentation, which you will still find helpful: https://youtu.be/e-UTXSFwHaw
Much more information on FDA submission pathways and the ever-changing EUA process at https://leanraqa.com/