Classifying your medical device or in vitro diagnostic device (IVD) under the FDA is one of the first steps in the market authorization process. As early as the device design phase, it is important to understand how your device’s characteristics will impact its classification and, as a result, your regulatory obligations. In this article, we will explore how medical devices and IVDs are classified under the FDA, how to determine the correct classification for your device, and how it impacts your regulatory requirements.

US FDA Classification Scheme for Medical Devices and IVDs 

Let’s start with a history lesson on the FDA and how it initiated its regulation of medical devices and IVDs in the U.S. In 1976, the FDA introduced the Medical Device Amendments to the U.S. Food, Drug, and Cosmetic Act, establishing a three-tier hierarchy for classifying medical devices and IVDs according to their level of risk to the patient or user. Working with different panels of experts, known as “Classification Panels,” the FDA began the initial classification of medical devices and IVDs, a process that was not completed until the mid-1980s.

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Class I – Low Risk 

Class I devices pose minimal risk to the patient and their overall health. According to the FDA, Class I devices do not:  

• • Support or sustain life;  

• • Substantially prevent impairment to human health; or  

• • Present unreasonable risk of illness or injury.  

Examples of Class I devices include a reusable surgical scalpel, certain hearing aids, or a tongue depressor. 

Most Class I devices have minimal regulatory obligations. In general, they do not require a Pre-market Notification, also known as a 510(k), which is a dossier of information about your device similar to a European Technical Documentation File. However, they do require a quality management system that complies with the applicable sections of 21 CFR Part 820 and adherence to FDA General Controls. 

Class II – Medium Risk 

Class II devices pose moderate risk to the patient and their overall health, often because they come into direct contact with the patient. The FDA defines a Class II device as one for which general controls are insufficient to ensure safety and effectiveness. Class II devices can be relatively simple, like surgical gloves, or more complex, like a bone sonometer.

Most Class II devices require Pre-Market Notification, or a 510(k). However, some Class II devices may be exempt from a 510(k). They also require adherence to FDA General Controls and Special Controls. Special Controls are specific to your device and can include additional testing, labeling, data, or post-market surveillance (PMS) requirements

Class III – High Risk 

Class III devices pose a life-threatening risk to patients or a risk of serious injury. According to the FDA, a Class III device is life-supporting or sustaining, and/or is implanted in the body, and/or poses an unreasonable risk of death or serious injury. Class III devices are often very sophisticated technologies, such as ventilators or software as a medical device (SaMD) that pairs with a blood glucose meter to administer insulin and regulate blood sugar levels. However, they can also be relatively simple devices designed for use in high-risk treatment scenarios or areas of the body, such as an ophthalmic surgical scalpel.

The path to market for Class III devices is grueling, with many requiring Pre-market Approval (PMA), though some can qualify for a 510(k). A PMA is an exhaustive regulatory application that requires extensive clinical data, including data from clinical studies. The FDA will also conduct a thorough review of your quality management system as part of its pre-market review.

How to Determine FDA Classification for Your Medical Device or IVD 

FDA classification is different from classification schemes in other markets. In most regulated markets, a rules-based system is followed, which allows manufacturers to determine their device’s classification based on its characteristics. However, device classification in the U.S. is based on the classification of existing devices under the FDA’s Food, Drug, and Cosmetic Act, which is subsequently published in the FDA Code of Federal Regulations (21 CFR Parts 800-1299) and in the FDA’s public databases.

Option One: Search the web for “FDA Device Classification database.” From this database, you can search by the device name, e.g., “blood pressure monitor” or “dental implant.” All device types associated with the search term will appear, and you can select each device type, review the applicable device definition, and identify the device classification.

Option Two: Search the web for “FDA Device Classification database.” From this database, you can search by the FDA’s “Review Panel,” of which there are 20. After selecting the appropriate “Review Panel,” you will be presented with all devices associated with the identified “Review Panel.” You can then select each device type, review the applicable device definition, and identify the device classification.

Option Three: Search the web for “FDA Device Registration database.” If you know the name of a similar/comparable medical device or the manufacturer of a similar/comparable device, you can search by either the specific device name, e.g., “OneTouch” or “Kardia Mobile,” or the manufacturer name, e.g., “Masimo” or “LifeScan.” You can then select the specific device type and identify the device classification.

Regardless of the search option(s) you select, if you identify a device within the FDA’s databases that is similar to your device, you will now have a classification for your device, except in unusual circumstances, and the FDA will provide a three-letter Product Code, e.g., DXN (for blood pressure measurement system), for the device. With the knowledge of the Product Code, you can identify your classification and, importantly, all medical devices registered with the FDA with the same Product Code.

What If My Device is “Novel” and I Can Not Identify a Similar Device? 

If after executing the three search options listed above you cannot find a device in FDA’s databases, you have several options: 

513(g) Request for Information 
You can submit a request to FDA for a formal device classification, called a 513(g). The process does carry a fee but can provide invaluable guidance before moving forward with the regulatory submission process. In response to your request, FDA will determine if your device qualifies as a medical device, provide guidance and recommendations on classification, and identify the applicable regulatory pathway, e.g., FDA 510(k)m PMA (Pre-Market Approval) or De Novo is required. NOTE: Determinations regarding substantial equivalence or specific predicates are not included in FDA’s response. 

FDA Pre-Submission Meeting 

Important Considerations When Searching for the Device Classification  

If you have identified what you believe to be the appropriate device classification and Product Code, it is important to also consider the “intended use” and “indications for use” of your device and similar devices that may be registered with the FDA. The intended use and indications for use are key statements about your device and what it does. It’s important not to confuse them, as they are quite different, even if they seem similar.

Intended use is a succinct, basic description of your device and what it does. For example, the intended use statement for a tissue adhesive is: “intended for the topical closure of surgical incisions.”

However, indications for use specify when, where, and how your device should be used and in which populations. A device can have numerous indications, which should be supported by clinical data. The indications for use for the tissue adhesive mentioned previously might include: “indicated for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. It may be used in conjunction with, but not in place of, deep dermal stitches.”

Your device’s indications for use can significantly impact its classification. For example, the tissue adhesive described above is likely a Class II device. However, a tissue adhesive indicated for internal use is Class III and will have a different FDA product code.

FDA Medical Device Classification with MedEnvoy

The FDA’s classification scheme is unique in the industry and can be frustrating and time-consuming to navigate. Choosing the wrong device classification and, depending on the regulatory pathway, the wrong predicate device can waste your time and delay your application. Our regulatory consultants have decades of experience classifying medical devices and IVDs. Our team is deeply familiar with the technologies and tools required to perform a classification assessment and identify potential predicate devices. Stop spending hours scouring FDA databases. Our team can quickly and efficiently determine your device classification for you, to contact our team, click here. To learn more specifically about our FDA service, click here.

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