Medical device classification in the USA – part 1.
As already mentioned in the general article on MD regulation, in the United States there is a unified regulatory system for MD, meaning that there is no division into MD and MD for in vitro diagnostics. The same rule is applied to the MD classification.
In the USA MD classification is based on two criteria:
- Intended use including indications for use;
- The risk the device poses to the patient and/or the user.
It is worth noting the difference between the intended use and indications for use since this matters in the US MD classification.
Intended use means the general purpose of the device or its function and encompasses the indications for use.
The term indications for use describes the disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended.
It is important that the indications for use, along with the proposed labeling, play a role in determining the intended use and, as a result, determine the class of the medical device. Consistency between the indications for use statement and the proposed labeling will facilitate the review of the 510(k).
For example, when registering MD of the first risk class, it is important to find similar products, i.e. having the same indications for use. In case the indications differ, the FDA will need to understand whether the intended use of the device and the registered equivalent is the same and how “similar” the effectiveness and safety of the MD is to the registered one.
There are cases when the intended use = indications for use. This applies to devices such as some scalpels that are designed to cut tissue or to imaging devices that are designed to obtain images of body parts under various conditions (“tool type” indications).