How Indications for Use Impact Medical Device Classification

Before you begin the regulatory process for your medical device, you need to know its classification. Whether you’re eyeing a launch in the US or Europe, classification will determine your regulatory pathway and the corresponding level of scrutiny your device receives.

Regulators consider a number of factors to determine your device’s classification, particularly its intended use or purpose. However, indications for use – the who, when, where, and how your device is used – play a significant role and are often misunderstood. In fact, changing just a few words in your device’s indications for use can significantly change your regulatory pathway.

Medical Device Intended Use vs. Indications for Use: What’s the Difference? It’s important to not confuse indications for use with intended use. Let’s take a closer look. Intended use describes the overall function and purpose of the device without specifying medical conditions or patient populations. The intended use statement is usually a concise, high-level description of the device and what it does. Indications for use, on the other hand, provide specific details about the medical conditions, diseases, or situations for which the device should be used. They narrow down the scope of application and identify the target population or specific patient characteristics. Indications for use statements should be supported by clinical data.

Let’s look at a few intended use and indications for use statements side by side:

Device Example	Intended Use Statement	Indications for Use Statement
Insulin pump	Intended for continuous subcutaneous delivery of insulin to manage diabetes.	Indicated for use in people with diabetes to administer a continuous and personalized insulin dosage to maintain blood glucose levels.
Personal EKG monitor	Intended for non-invasive recording and analysis of electrocardiogram (EKG) signals.	Indicated for use by adults who want to monitor their heart’s electrical activity. It is designed to record EKG signals and transmit the data wirelessly to a compatible mobile phone or smart device application. It can assist users in capturing EKG readings during episodes of palpitations, discomfort, or irregular heartbeats. The mobile phone application analyzes EKG results, displaying heart rate, rhythm, and potential abnormalities.
Blood glucose meter	Intended for measuring and monitoring blood glucose levels.	Indicated for use by individuals with diabetes to accurately measure and monitor their blood glucose levels in conjunction with a compatible mobile application that wirelessly receives and displays glucose data. This assists with day-to-day diabetes management.
MRI imaging software	Intended for rendering and analyzing MRI images using advanced artificial intelligence algorithms to enhance image quality and detect potential abnormalities.	Indicated as a supplementary tool for use by qualified healthcare professionals to assist in the interpretation of MRI images and aid in the detection, characterization, and measurement of potential pathologies or anatomical structures of interest and to support clinical decision making, diagnostic evaluation, and treatment planning.

 

Understanding US FDA Medical Device Classification

The US FDA imposes a three-tier classification system that corresponds to increasing device risk and more rigorous regulatory requirements:

• Class I (low risk)
• Class II (moderate risk)
• Class III (high risk)

Most Class II devices require a premarket notification 510(k) submission to FDA, with exceptions for low-risk, novel, or very high-risk devices. The 510(k) is a dossier of documentation about your device that proves it is substantially equivalent to a device already cleared by FDA, called a predicate device. Cleared devices are assigned a three-letter product code, which is used by FDA to identify and track similar device types.

How Indications for Use Affect Substantial Equivalence for FDA Device Classification

Your device’s indications for use must be consistent with the indications for use of your predicate device and its three-letter product code. FDA product codes are quite specific, and changing or narrowing your indications for use could change your device’s predicate and product code.

For instance, let’s say you plan to bring a tissue adhesive to market. If your adhesive is indicated for topical use for minimally invasive surgical incisions, it is likely a Class II device. If your adhesive is indicated for internal or ophthalmic use, it’s likely a Class III device and may even require a pre-market authorization (PMA). Also, it will have a different product code if it’s indicated for internal or ophthalmic use. Your regulatory obligations can become significantly more rigorous as you expand your indications for use, especially if those indications specify areas of the body or treatment scenarios that are inherently higher risk.

Software as a medical device (SaMD) leaves more room to be strategic when writing indications for use. Consider digital therapeutics, an area of healthcare that has exploded in recent years. They can treat a range of conditions from IBS to cognitive impairment. But when it comes to their indications for use, digital therapeutics manufacturers can move the needle on regulatory obligations by choosing their language carefully. Is their platform intended to treat or treat and diagnose? Is it prescription-only or available over the counter? Words matter, especially when it comes to software.

Understanding EU Medical Device Classification

Similar to FDA, devices are also classified into tiers of increasing risk under the EU Medical Devices Regulation (MDR 2017/745):

• Class I
• Class IIa
• Class IIb
• Class III

Predicate devices have no bearing on your EU classification; the system is entirely rules-based. If multiple rules apply to your device, the rule with the highest risk association will determine its classification. For example, an invasive device intended for short-term use (Class IIa) that has direct contact with the heart (Class III) is a Class III device.

The EU In Vitro Diagnostic Devices Regulation (IVDR 2017/746) enforces a similar system that comprises seven rules and four classification tiers (Classes A, B, C, and D).

How Indications for Use Affect Device Classification Under the EU MDR

EU classification rules start with three major categories for intended use: Is your device non-invasive, invasive, or active? From there, you can follow the rule logic to determine your device classification. Device indications further inform which rules apply to your device.

The classification implications for the adhesive device discussed earlier are similar in Europe. A topical adhesive could be considered a non-invasive Class IIb device; however, an internal adhesive – especially one that comes into contact with the heart – could be an invasive Class III device.

The MDR draws clear lines on indications for use for medical device software. Software intended to provide information used in diagnostic decisions or therapeutic purposes is Class IIa. However, there are conditions based on the software’s indications for use with respect to populations, diseases, and imminent threat to health. For instance, medical device software that analyzes images for patients with serious conditions, like acute stroke or heart attack, would be a Class III device. Software that diagnoses depression based on the patient’s symptom data would be upclassed to a Class IIb.

Need Expert Help Classifying Your Medical Device?

It’s very important that you think carefully about the indications for use of your product and any future ambitions you have for expanding those uses. As noted in the example above, a simple change in indications can have profound impacts on classification and the cost and time you will invest in obtaining approval and maintaining compliance. If you’re embarking on the regulatory process for the first time – or are unsure about the impact of a proposed indication for use – let our experienced consultants look at your situation and determine your device’s classification in the US and EU, so you can choose the most efficient regulatory pathway.

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