May 13, 2025

When beginning the process of introducing a new medical device to market in the United States, it is crucial that manufacturers properly understand the FDA’s risk-based regulatory classification system of these devices. Based on the level of risk the device could pose to patients as well as the necessary regulatory controls required to ensure the product’s safety and effectiveness, devices are classified into one of three classes: Class I, II, or III. In addition to these classifications, new and innovative technologies may be required to follow more rigorous approval pathways, as additional data and regulatory controls may be required to properly prove the product’s safety and efficacy prior to market approval.[1]

Understanding where a device falls within this classification system is critical, as it directly impacts every aspect of the regulatory process. A device’s classification determines the appropriate regulatory pathway, including the scope of testing, documentation, and premarket review required before it can be legally marketed. It also informs the design and development process by establishing the necessary controls to ensure the product’s safety and effectiveness. Moreover, knowing the classification early on helps manufacturers estimate the cost and time needed to reach the market, enabling more accurate planning and resource allocation. By identifying a device’s classification from the outset, developers are better positioned to navigate regulatory requirements efficiently and avoid costly delays on the path to FDA approval.[2]

Medical Device Classifications in the US:

Class I

Class I medical devices are considered low risk and, as such, do not require pre-market approval by the FDA. Common examples of devices that would fall into this category include everyday items such as bandages, examination gloves, and tongue depressors. While no pre-market approval is required, these products are still subject to general regulatory controls outlined in the Federal Food, Drug, and Cosmetic Act, including meeting requirements for appropriate labeling, device and facility registration, good manufacturing practices, and proper documentation. Due to their lack of premarket approval and frequent exemption from strict quality system rules, these devices are often the simplest to introduce to the market. However, it remains critical that manufacturers of these low-risk products meet all applicable general controls, such as implementing a quality management system and adhering to relevant industry standards to guarantee the safety and effectiveness of their devices, to ensure continued compliance and avoid enforcement actions.

Class II:

Class II devices present a moderate level of risk and require special controls in addition to general regulatory controls to ensure the product’s safety and efficacy. Special controls may include specific labeling requirements, performance criteria, tracking patient data, post-market surveillance, and, most commonly, the submission of a 510(k) regulatory application to show that the device is substantially equivalent to an existing, legally marketed predicate device.

For devices that incorporate new technologies or intended uses for which no appropriate predicate exists, manufacturers may instead need to pursue the De Novo regulatory pathway for their submission. This alternative route allows novel, low-to-moderate-risk devices to be classified and approved without proving substantial equivalence, provided that the applicant is able to present sufficient evidence of the device’s safety and efficacy. However, for new, low-to-moderate risk devices without a comparable existing device, the De Novo pathway allows them to be classified as either Class I or II, avoiding the more rigorous PMA process.

Examples of Class II medical devices include catheters, infusion pumps, blood pressure cuffs, and pulse oximeters; products that are widely used in clinical settings and require careful oversight but do not pose the same level of risk as Class III devices. While the regulatory burden is greater than for Class I devices, the 510(k) and De Novo pathways offer relatively efficient routes to market when approached with proper planning and regulatory support, and significantly less regulatory controls than Class III devices.

Class III:

Class III devices are considered high-risk as they are often life-sustaining, life-supporting, or essential in preventing severe health conditions, and if they were to malfunction, may result in significant injury or death. Due to their risk profile, Class III devices are subject to the most stringent regulatory controls and must undergo Premarket approval (PMA), the FDA’s most rigorous review process, prior to entering the US market.

For most new Class III devices, PMA is the standard pathway to market approval. The PMA process requires manufacturers to provide substantial scientific evidence, including clinical trial data, to demonstrate that the device is safe and effective for its intended use. [6] This process often involves in-depth FDA review of design, manufacturing processes, labeling, and post-market plans, and can take considerably more time and resources than 510(k) or De Novo pathways to achieve market approval.

Examples of Class III devices include implanted defibrillators, cardiac valves, pacemakers, and deep brain stimulators. Because of the rigorous regulatory requirements associated with these high-risk devices, early attention to development, testing, and documentation is key to supporting a successful submission and maintaining compliance throughout the product’s lifecycle.

While most medical devices follow a clearly defined classification framework and regulatory pathway, there are important exceptions that allow for, or even require, alternate approval routes. For instance, some Class I devices, despite being considered low-risk, may still require a 510(k) submission if specific safety concerns are identified. Likewise, while most Class II devices must submit to the 510(k) process, certain products may be exempt if they meet specific criteria demonstrating safety and efficacy; devices that meet these criteria are known as “510(k) exempt devices”.

In certain rare cases, even Class III devices, which normally require Premarket Approval (PMA), may be eligible for a 510(k) submission. This applies primarily to certain Class III preamendment devices that were marketed prior to the 1976 Medical Device Amendments and have not been reclassified. In this instance, these devices may qualify for a 510(k) submission instead of undergoing the extensive PMA process. However, this route is becoming less common as the FDA shifts to more comprehensive safety evaluations.

While these exemptions are not particularly common, these exclusions can significantly impact regulatory processes and market entrance strategies, so it is critical that medical device developers keep them in mind early in the product development process.[3]

General Wellness Products

Another important exception that could have a significant impact on manufacturers regulatory strategies is if the product qualifies to be classified as a general wellness product. This product category, established by the FDA in 2016, classifies devices or tools designed to support a healthy lifestyle, rather than diagnose or treat medical conditions, as General Wellness devices. These products fall into two categories: (1) those that promote overall well-being, such as fitness trackers or meditation apps, or (2) those that suggest healthy habits can help lower the risk of certain diseases such as smartwatches that remind you to stay active to support heart health. The key point is that these products focus on encouraging healthier choices rather than providing medical treatment, and fall outside of the regulatory controls that govern medical devices [5].

Understanding whether a health-related product is a medical device or a general wellness product is crucial when introducing it to the market. General wellness products, if deemed low risk, are exempt from FDA regulation, which affects everything from labeling requirements to approval procedures. However, manufacturers must be especially careful to ensure that product packaging, labeling, and promotional materials do not inadvertently include claims that could reclassify the product as a medical device. The table below outlines the main distinctions in navigating classification-dependent regulatory pathways. [4]

Medical device classification directly impacts regulatory requirements, development costs, and market entry timelines. Class I devices face minimal oversight, while Class II and III devices require stricter controls, such as 510(k) clearance, De Novo classification, or PMA, with increased testing and approval timelines. Understanding classification early allows manufacturers to streamline approval, manage costs, and accelerate market entry, ensuring compliance and promoting product success.

Incorrectly classifying a medical device can have serious downstream consequences for manufacturers, especially startups and innovators with limited resources. A product miscategorized as lower risk may advance through early development with insufficient testing or documentation, only to face rejection at the FDA submission stage—requiring rework, costly delays, or even a complete redesign. On the other hand, overestimating classification can lead to unnecessary studies, inflated budgets, and missed speed-to-market opportunities.

Class II and III devices face heightened scrutiny, including requirements for clinical testing, substantial equivalence arguments (510(k)), or, in the case of novel technologies, De Novo or PMA submissions. These pathways come with distinct timelines and data expectations that should be mapped out from the beginning. Engaging early with the FDA through programs like the Pre-Submission (Pre-Sub) process can clarify classification questions and reduce regulatory uncertainty.

Staying informed about evolving FDA guidance, including updates to the 510(k) and De Novo processes, helps teams make informed decisions about device positioning and approval strategy. Proactive alignment with regulatory expectations supports faster, more predictable product development and increases the likelihood of market success.

Navigating the FDA’s medical device classification system is essential for manufacturers and innovators aiming to bring new products to market efficiently and compliantly. Understanding whether a device falls into Class I, II, or III (or general wellness) determines the level of regulatory scrutiny, testing, and approval pathway required, directly impacting development timelines and costs. Early engagement with the FDA, careful regulatory planning, and compliance with evolving guidelines can help manufacturers streamline the approval process, reduce risks, and ensure their devices meet safety and effective standards. Proactively addressing regulatory requirements ensures a smoother approval process, strengthens product credibility, and enhances patient safety and healthcare outcomes.

References:

1.https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification

2. https://www.greenlight.guru/blog/medical-device-regulatory-classification

3. https://www.thefdagroup.com/blog/pma-vs-510k

4. https://nysstlc.syr.edu/general-wellness-v-medical-device-considerations/

5.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices

6. https://www.qualio.com/blog/fda-medical-device-classes-differences

Anand Bhati

Anand Bhati is a Regulatory Affairs Writer with experience in regulatory submissions, risk management, and global compliance for medical devices. He holds a Master’s in Regulatory Affairs from Northeastern University. His experience includes supporting 510(k) submissions, risk assessments, and regulatory strategy development for medical devices. He has contributed to post-market surveillance initiatives, clinical compliance tools, and vigilance reporting, ensuring adherence to FDA and international regulations. With a strong focus on cGMP compliance and quality systems, Anand is committed to regulatory excellence and facilitating market access for healthcare innovations.