While the ability to market medical products is bound by the claims that can be lawfully made, it does not mean the claims available at acquisition are all your company will have. Consider developing a plan to create additional claims, but keep in mind the following. Does the desired new claim require a labeling change? Relying on FDA’s June 2018 guidance, Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers, will help answer the first question. Next, consider the type of evidence needed, will pre-clinical evidence give you the claim you seek, or is a full clinical trial necessary? If there is uncertainty regarding any of this, consider a pre-submission with FDA to provide more clarity. New claims will allow you to reach more customers but understanding what it will take to actually receive that claim will provide predictability for your company.

When working through an acquisition, it is important to understand the claims you can make, not just the claims you want to make. Proper due diligence before an acquisition and a solid plan for after the acquisition will provide predictability for your business. The ultimate goal is to have claims that are both compelling and compliant that allow you to impact patient lives. For additional insight on this topic, watch our recording from this recent program.