What is the Product’s Intended Use?…a Simple Question With a Big Impact on the Success of Your Regulatory Strategy
February 27, 2023
You’ve no doubt heard the old adage, “measure twice and cut once.” It applies to many things, including the creation of a regulatory strategy.
After 35 years in the industry, including teaching regulatory principles these past seven years to successful regulatory professionals (even some who now work at the FDA), I don’t know it all. But I know enough to know when I see a losing regulatory strategy. The frustration increases when I can see why it happened and how it was avoidable.
The absolute path to a winning regulatory strategy is an Intended Use statement. Without a solid one – right out of the gate – anything you do will simply be a guess, and lead to wasted time and money.
The Intended Use Statement is simply an answer to the question, “What does the product do?” Creating the statement should not be difficult after all the feasibility work that most developers conduct. Yet it can be easy to get so caught up in technical details and the intricacies of the product development process that this top-level, guiding purpose can become lost.
Light post for your product
The Intended Use statement has three important purposes that shape the life of your regulatory strategy and path to market.
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- FDA definition: The statement is used to make sure the product meets the FDA’s definition of a medical device. As logical as that may sound, there are plenty of examples where a device is already down the 510(k) path when the developer discovers it does not meet the definition of “medical device.”
- Risk level: The Intended Use statement is used to determine the risk associated with the device (non-significant versus significant), and the associated classification of the device.
- Class I: the lowest-risk device subject to General Controls.
- Class II: a device with more associated risk that requires additional Special Controls, including a demonstration of substantial equivalence against a predicate in a 510(k) submission. A predicate is a device that has received 510(k) clearance and made it through the de novo process. It’s impossible to select the right predicate for your product in the absence of an Intended Use statement. A determination of substantial equivalence requires two elements; the same Intended Use, and the same or similar technological characteristics that don’t raise new questions of safety or effectiveness.
- Class III: the highest-risk device – usually a life-sustaining, life-supporting and/or implantable device that requires FDA’s approval in lieu of clearance.
- FDA definition: The statement is used to make sure the product meets the FDA’s definition of a medical device. As logical as that may sound, there are plenty of examples where a device is already down the 510(k) path when the developer discovers it does not meet the definition of “medical device.”
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- Database search: The key words from the Intended Use statement are the ones that the Center for Devices and Radiological Health will use for search in the product code database. Identification of the product code is extremely important, as it guides the corresponding controlling regulation, the level of control required (General and/or Special) and the required regulatory submission type (510(k), 510(k-exempt, PMA).
Use of the Intended Use statement as your regulatory strategy guide
In developing a regulatory strategy, nothing is more informative than FDA’s website; that should always be the most important guiding light. But first-hand experience – combined with a deep respect for the FDA and our shared mission – confirms the importance of the Intended Use statement in determining the effectiveness of a regulatory strategy, and ultimately, your path to market.
As you look at creating your Intended Use statement, wait until you can state, as definitively as possible, what the product is designed to do. This statement then can, and must, guide your product development process. While you will likely make tweaks along the way, if you are working with a carefully and thoughtfully crafted Intended Use statement, you will assure a faster, clearer, more efficient path to market.
Conclusion
After earning more than a few Ph.D. degrees at the University of Hard Knocks, I can verify that effort at the onset to create the Intended Use statement will pay off. Just as “measure twice and cut once” pays off in construction, sewing and countless other applications, making the effort with the statement will dramatically increase your chances to get your product through the regulatory process and on to the market.
By Joanne Rupprecht, former Senior Vice President, Regulatory and Quality, Boulder iQ