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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.
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)
“Intended Use” is therefore the “Objective Intent” for the device of the persons legally responsible for labeling the device. It is in fact a regulatory term that paints a distinctive and overall picture to define what the product is intended for. Unlike “Indications for Use” (which we’ll get to in a minute), the Intended Use does not necessarily come in a written paragraph form. It is constructed by several media including: labeling, word of mouth, and advertising.
A change to Intended Use is usually considered for a new submission when it could significantly affect the safety or effectiveness of the device. Such things as the change from prescription to over the counter use is one example when a device would require a new 510(k). Another example when a change is considered significant is when a device goes from single use to multi-use.
INDICATIONS FOR USE
Unlike Intended Use where the term is used in a very regulatory fashion and can be derived by several input avenues and is amorphous in nature, Indications for Use has a very definite structure.
Indications for Use is defined by the FDA as:
The general statement of the "Indications for Use" identifies the target population in a significant portion of which sufficient valid scientific evidence has demonstrated that the device as labeled will provide clinically significant results and at the same time does not present an unreasonable risk of illness or injury associated with the use of the device. As appropriate, the labeling should state that the device (trade name) is "indicated" or "intended for use"
(1) in the treatment, mitigation, prevention or diagnosis of a recognized disease or condition or an important manifestation of a disease or condition; and/or,
(2) in the relief or mitigation of symptoms associated with a disease or condition; and/or,
(3) as an aid or adjunct to a mode of therapy or diagnosis..
Depending on what type of device you are writing the Indications for Use statement (diagnostic or therapeutic) there should be several specific elements to your statement.
Levels of Specificity for diagnostic medical devices:
Identification or measurement of a physical parameter (e.g., image, heart rate) or biochemical parameter (e.g., analyte)
Identification of a new or specific target population (e.g., women, children of a certain age range) or anatomical location (e.g., MR of the brain)
Identification of the clinical use of the measurement (e.g., diagnosis, screening)
Identification of or implication of an effect on the clinical outcome (e.g., screening mammography reduces breast cancer mortality)
If your device is diagnostic in nature it should have at a minimum these specific descriptions.
For therapeutic devices:
Levels of Specificity for therapeutic (including preventive) medical devices:
Identification of function (e.g., cut)
Identification of tissue type (e.g., soft tissues)
Identification of an organ system (e.g., GI tract ) or
Identification of a specific organ (e.g. liver)
Identification of a particular disease entity (e.g., resection of hepatic metastases) or target population
Identification of an effect on clinical outcome (e.g., use of medical device improves the rate of durable complete remissions with chemotherapy)
For a more detailed analysis of the specificity to which one should set their Indications for Use statement see the FDA guidance document:
Guidance for Industry: General/Specific Intended Use
In conclusion, the Indications for Use statement, as defined by the FDA, has very precise structure. The Intended Use on the other hand is a regulatory term that describes an overall picture. You are still responsible for defining Intended Use and ensuring that your product is used as such. In the end your submission package will be spearheaded by your Indications for Use statement. You will be held accountable for what you put in it as well as what you leave out.
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