Ulmer Ventures

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Why you should talk to the FDA

There is a broad spectrum of advice MedTech companies receive regarding when, how, and on what topics to engage the United States Food & Drug Administration (FDA). Here is part 1 of the top 10 reasons it makes sense. I also share my thoughts on a common myth and reality when speaking to the FDA.

1. It signals that you have a strategy
This is a nuanced point. Persons who believe in the company will appreciate that you understand the key sequence of steps to launch a product and the fact that the most efficient path to market is by gaining an early understanding of a regulatory body's requirements and cost.

2. You de-risk the product launch for investors
Financial backers will want to know more than the blanket 6 month estimate for FDA clearance. They will understand and appreciate that written feedback from the FDA trumps any internal assessment and provides an objective road map to clearance.

3. You gain an objective tool to evaluate your regulatory team or consultant
The written feedback can be used to assess knowledge and skill gaps in your team. Since the Pre-Submission includes no additional cost to the company, you get "free" feedback on how your team critically organizes their regulatory thinking, articulates a strategy and performs in a high pressure call or face-to-face meeting.

4. The regulatory leader's voice gains validation
Organizations large and small will have multiple voices regarding risk to the company given a chosen regulatory strategy. To gain credibility and a stronger voice, the regulatory leader has the opportunity to guide the company through a complex interaction with a key stakeholder - the FDA.

5. You gain clarity on competitive advantage
If the technology you plan to launch is truly novel (De Novo), the FDA will likely acknowledge this in written feedback and provide the marketing team an optional additional talking point for product launch.

Pre-Submission Myth & Reality
Myth: You will get more FDA questions and a company can save time by simply submitting the formal application.

Reality: The list of FDA responses to questions posed by the company would likely be no more than what is in a deficiency list during a substantive application review. The same levels of FDA management review takes place for the formal application process and Pre-Submission process. A common company benefit is that a Pre-Submission may help avoid the cost of clinical trial(s) that is not properly powered and sized.