Can you explain the difference between intended use and indications for use? The terms are NOT interchangeable, but you can’t have one without the other.
If you said that 𝗜𝗻𝘁𝗲𝗻𝗱𝗲𝗱 𝗨𝘀𝗲 refers to the core objective at the basis of the FDA regulations, then you get a gold star.
Intended use is the intent (or purpose) for your device that can be shown via labelling, advertising, oral/written statements and implied or expressed claims.
If you were writing the Intended Use for your medical device, you would write something like this:
Intended to provide intraosseous access in patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases.
This clearly states the purpose for which the device was designed, it’s ultimate reason for being on the market.
Conversely, the 𝗜𝗻𝗱𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗨𝘀𝗲 specify the anatomical sites, target population and duration of use for the device.
If you sat down to write the Indications for Use for your medical device, you would write something like this:
In the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatric patients, and the distal femur in pediatric patients for up to 24 hours.
This statement covers all three requirements and very clearly indicates where, when and how the device is to be used.
The Indications for Use arise from the Intended Use, because you can’t have indications without intention. Setting your intention and indications are the first steps along the path to market. The next step is deciding whether your product should be classified as a medical device – but that is a blog post for another day.
At the end of the day, your regulatory strategy only works if it survives contact with real-world execution.
If you’re looking to sanity-check where you are:
- Compare your current approach to what’s outlined in The Five Steps to Market: Define the Product
- Or here: FDA Regulatory Pathways Explained: 510(k), de novo, PMA, Pre-Subs & eSTAR
- And if you prefer a more structured walkthrough, Medical Devices 101: An Entry Level Overview of the FDA will show you how this actually plays out in practice
None of this is complicated—but it does require consistency, which is usually where things get interesting.
