Intended Use vs. Indications for Use: Key Differences Explained
As the medical device industry is undergoing rapid development , clear communication is an important aspect not only for regulatory compliance but also to ensure patient safety and entering the market successfully. “Intended Use” and “Indications for Use” are the terms that have been frequently used in this industry. Although these terms may appear to be similar at first, they have different meanings and impact. In this article, we will look into the above terms, understanding intended use vs indications for use, their significance, and the challenges faced by the manufacturers in defining them precisely.
Defining the Terms
Intended Use refers to the general function or purpose of the medical device as envisioned and claimed by the manufacturer. It encompasses the objective intent of the medical device as articulated in accompanying documents, advertisement materials and promotional materials including instructions for use, manuals etc. This objective intent is determined based on their expressed claims or the circumstances surrounding the device’s distribution. Such intent may be demonstrated through labeling, promotional materials, or any oral or written statements made by or on behalf of the manufacturer.
Indications for Use statement is a subset of intended use and delineate the specific medical conditions or situations in which the device is to be used. This includes a description of the disease, condition, or disorder the device would diagnose, treat, prevent, cure, or mitigate and the targeted patient population. For example, a wearable cardiac monitor’s indications for use might specify that it is intended for adult patients with a history of arrhythmia for continuous monitoring and early detection of abnormal cardiac activity.
The IFU may specify specific patient populations (e.g., adults or pediatric patients) or particular conditions under which the device is used.
The Importance of Distinguishing Between the Two
Understanding the distinction between intended use and indications for use is crucial for several reasons:
1. Regulatory Compliance:
Regulatory authorities like FDA evaluate both intended use and indications for use to determine the applicable classification and regulatory pathway for the device. Such accurate definitions ensure that submissions meet regulatory requirements and allow a smoother path toward approval. Intended use is also important in determining Substantial Equivalence.
Evaluating Substantial Equivalence in Premarket Notifications (510(k)), there can be cases where the Intended Use is the same between the predicate device and the subject device, but the Instructions for Use (IFU) may differ, and this can still support a claim of substantial equivalence.
An example where Intended Use can be the same, but the Instructions for Use (IFU) can differ, is:
● Predicate Device: A digital thermometer for measuring body temperature in adults in clinical settings.
● Subject Device: A digital thermometer for measuring body temperature in pediatric patients at home and in clinical settings.
The Intended Use of both devices is the same, as they measure body temperature for medical purposes, but the IFU differs, with the subject device addressing pediatric usage and home settings, while the predicate device focuses on adult patients and clinical settings. Hence, it is essential to clearly distinguish and define the Intended Use and Indications for Use.
2. Patient Safety:
Indications for Use statement provides information about the health and use conditions that influence patient safety. Precise indications for use and intended use can reduce use errors, adverse events, thereby increasing the product reliability. Informed decisions are taken regarding the application of the device, thereby ensuring its safety and effectiveness by using the correct definition.
3. Market Success:
Indications for use and intended use determine the on-label and off-label claims regarding the product’s safety and efficacy in the labeling and promotional materials. Healthcare institutions and professionals rely on this information for making use of a medical device. These definitions also play an important role in reimbursement services such as the CMS (Centers for Medicare & Medicaid Services). A well-defined IFU can build trust in the device and help avoid troubles with the FDA.
Challenges in Defining Intended Use and Indications for Use
While describing these two terms, the challenges faced by the medical device manufacturers are:
⦿ Ambiguity in Language:
Any regulations that are missing clear definitions may cause misunderstanding. Definitions must be clear, precise, and unambiguous to ensure clarity in the product documentation.
⦿ Evolving Technology:
With the rapid advancement of technology, the lines between intended use and indications for use has become increasingly blurred. Thus, a manufacturer has to be aware of all the technological advances and put limits on the usage of the device to mitigate any risks associated with off-label use.
⦿ Global Harmonization:
These terms may be interpreted by various countries in completely different ways and may have different requirements depending on the existing norms. Manufacturers can address this by engaging with international regulatory consultants and staying updated on regulatory changes in target markets, especially in light of efforts toward international harmonization.”
Conclusion
A clear understanding of both “Intended Use” and “Indications for Use” required in the medical device industry given the complexity of regulations. The above terms not only cause an impact on regulatory compliance but they also cause an impact on the market success and patient safety. Manufacturers can easily navigate the regulatory environment by addressing the challenges associated with these terms. This will thereby help in ensuring that the device reaches the market successfully and is also used safely and appropriately.
