Over the years, the amount of regulatory terminology seems to grow at a constant rate, and so it is no surprise that even the more fundamental terms start getting confused. We have seen many cases in which “Intended Use” and “Indications for Use” have been used interchangeably. Sometimes, “Indications for Use” are not even considered! So why does it matter?
The “intended use” of a device is critical for determining its classification, and is usually defined during the initial regulatory stages. However, the “intended use” is often misunderstood. Its purpose is not to describe what the device is intended to be used for. Instead, it should lay out the claims of what your device is meant to do. This is precisely why the classification will be based on the intended use, that is, on the manufacturer’s claims. It is good practice to keep the intended use statement concise, as long as it details all the fundamental claims appropriately.
On the other hand, the “indications for use” will lay out the conditions in which the user would use the device, that is, the reason or situation for use.
If you have any further questions, please let us know!