The last post was about capturing User Needs for your medical device project. Related to User Needs is the indications for use. Another term that is often used is intended use. There are some debates about the difference between intended use and indications for use. For the sake of this post, I’m considering these two terms to be synonymous–or at least similar enough that debating the nuances and differences is trivial.
Part of a FDA 510(k) submission is the Indications for Use statement. According to FDA:
The statement should include specific indications, clinical settings, define the target population, anatomical sites, etc. This statement must be consistent with your labeling, advertising and instructions for use.
As you can see, the Indications for Use is very much related to User Needs.
Which comes first? User Needs or Indications for Use? I guess it doesn’t really matter. The point is, you need to have both. And you should be documenting both very early in the medical device product development process.
We’re working on a product development project where we are in the process of establishing and defining the indications for use. This is important due to the regulatory implications and classification for the product. Knowing the desired indications helps us determine possible FDA product codes, which in turn dictate classification and type of clearance required (same is true for EU, Canada, and in many other places in the world).
With the draft indications for use, we were able to identify possible product codes and classifications. Some of the options are class I, others class II requiring a 510(k). Knowing the desire to get to market quickly, we are able to identify ways to modify the product User Needs and Indications for Use in such a way that would allow our team to first pursue the class I product codes options. The Indications for Use help us to define what the product can do, how it can be used, and how to eventually market the device.