- Find Regulatory Requirements for your country
- GHTF
- Validation Requirements
- Medical Device Software
- Sterilization
|
SUBSCRIBE (always Free) |
|
FDA’s “Intended Use” and “Indications for Use”
Special attention should go into the construction of these terms when applying to devices that are submitted to the FDA. However despite sincere efforts a lot of manufacturers still get it wrong.
The meanings of “Intended Use” and “Indications for Use” have very specific meaning and legal implications when fulfilling FDA requirements. Constructing these terms should be left to individuals that have precise understanding of the FDA’s intent. Additionally many larger organizations actually have their legal department take a stab at it before releasing to the FDA.
SPECIAL CONSIDERATION FOR “Indications for Use”
Before we get into describing the FDA’s perspective on these two terms consider this. The FDA reviews tons of data and information related to a submission [let’s say a 510(k)]. Most of the data you submit is used to support the safety and efficacy claims that are made in your “Indications for Use” statement. If however your product was tested for feature “B” but is left out of the “Indications for Use” statement you are not automatically cleared for that feature. In actuality your product is cleared for the uses as specified in the “Indications for Use”.
Does that mean you should cram your “Indications for Use” statement with as much information as possible? Hardly. Doing so will bind your organization to the what was stated. Remember, that changes – any changes – to the statement require that you resubmit your entire 510(k). The best way to tackle the construction of the “Indications for Use” is to balance. Keep it as short as possible but concise enough that you can review all your indications and answer the question: Does this “Indications for Use” statement cover this? If you answer “yes” than you probably have enough information. However, as we shall see later there is a minimum level of specificity that the FDA requires you to have.
INTENDED USE
The FDA defines “Intended Use” as:
The term "intended uses" refers to the objective intent of the persons legally responsible for the labeling of the device. The intent is determined by their expressions or may be shown by the circumstances surrounding the distribution of the device. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such representatives. It may be shown by the offering or the using of the device, with the knowledge of such persons or their representatives, for a purpose for which it is neither labeled nor advertised. (21 CFR 801.4)