Thoughts on the FDA and the Class III pathway.

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, offering insights into the nature of interactions with the FDA, the importance of strategic planning, and the financial implications of pursuing Class III approvals.

Distrust – The FDA is not your friend, even though they will seem nice and friendly and helpful.
Politics – The FDA culture makes decisions based on internal politics NOT science or clinical data.
Volatility – Nothing that the FDA communicates to your company is “binding”. They can change their mind anytime and they will.
Turnover – The FDA employees will change over the years. It’s a turnstill. Do not be surprised if you will be dealing with new FDA representatives during your journey.
Caution – Do not share anything with the FDA unless you absolutely have to. The less information they have the better. The more data you share with the FDA, the more it feeds their questions and creates work for your company, and usually cost more time and money.
Strategy – Hire a super-strategic and entrepreneurial Regulatory Strategist, not a Regulatory professional who follows guidelines, crosses T’s and dots all the I’s.
Costs – The Class III pathway will cost probably 10 X the money you have budgeted and will take 50% longer than anticipated to get your approval. Please do worst-case financial planning.
Prudence – Remember, you don’t have to gamble your entire company to enter the US market, you can always have a nice OUS (Outside the United States) business without betting the entire company and 10 years of fundraising.