Thoughts on the FDA and the Class III pathway.

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Navigating the journey of a Class III regulatory approval in the US can be a daunting task for any ortho or spine company. The Class III process is fraught with challenges that can perplex even the most seasoned industry leaders. Understanding the intricacies of this process, the culture within the FDA, and the best strategies for engagement can make a significant difference in the outcome.
The Class III pathway can cost upwards of $100M and 10 years of work.
This blog post aims to shed light on some critical considerations companies must keep in mind as they embark on this journey, offerin...

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