Questions

When thinking about different activities or messaging to market my product, I often wonder what I should be careful or aware of when doing so.

Yes, absolutely there are very different rules that you have to follow for healthcare products. It mostly boils down to what you are claiming, and what the 'class' of your product is as defined by the FDA.

You have to go through an extensive process to get certain healthcare products approved by the FDA. And even when approved, it's only approved with certain restrictions on how you can market it.

I've worked with two startups on getting products through FDA, and worked with them on how to legally market their products before FDA approval (i.e. how to correctly abide by the restrictions while still being able to market).

If you'd like to discuss the restrictions more with respect to your specific product let me know,

all the best,

Lee


Answered 4 years ago

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