How to Classify Your Medical Device for FDA Approval
Companies looking to market and sell medical devices in the United States must obtain approval from the U.S. Food and Drug Administration (FDA). The first step to obtaining approval is classifying your medical device. This is a critical step, as it determines the type of premarket submissions and applications that will be required for FDA approval. It also helps you further define your regulatory requirements throughout the product lifecycle and set realistic commercialization milestones.
Most medical device manufacturers would agree that the classification process can be a daunting task. Where do you start and how do you know that your device is assigned the proper classification? Misclassification of devices can be a costly mistake due to the investment in unnecessary time and documentation, not to mention money. Here, we review the medical device classifications that are established by the FDA and provide the key steps to ensure your medical device is classified correctly.
FDA Medical Device Classification Criteria
- Intended use describes the general purpose or function of the medical device
- Indications for use describe the disease or condition the medical device will diagnose, treat, prevent, or cure. They also describe the target patient population.
Different regulatory controls (i.e., General, Special, or Premarket Approval) are assigned to each classification to provide reasonable assurance of the safety and effectiveness of the device. The amount of regulatory control increases as the device progresses from Class I to Class III.
- General controls apply to Class I, II, and III medical devices unless exempted by regulations. These controls include:
- Registration of device manufacturers (e.g., 510(k) premarket notification and device listing)
- Adulterated devices (not proper for use)
- Misbranded devices (provide false or misleading labeling)
- Banned devices
- Notifications and other remedies (i.e., notification, replacement, refund, reimbursement, or mandatory recall)
- Records and reporting on devices (i.e., adverse event, device tracking, unique device identification system, or reports of removals and corrections)
- General provisions respecting control of devices intended for human use (i.e., custom device, restricted device, good manufacturing practices (GMPs), devices for investigational use, devices considered as new drugs, or humanitarian devices)
- Special controls apply to Class II devices. They are usually device-specific and include:
- Performance standards (e.g., design characteristics or specifications)
- Premarket data requirements
- Postmarket surveillance
- Patient registries
- Special labeling requirements
- Guidance documents
- Premarket Approval (PMA) is required for Class III devices. As part of the PMA application, extensive scientific evidence in the form of laboratory and clinical trial data must be submitted to the FDA to prove the safety and effectiveness of the device.
If you are planning to introduce a new device to the U.S. market that does not require PMA, you will most likely need to submit a 510(k) premarket notification to obtain FDA clearance. The 510(k) is a faster and less expensive submission route that can be used if your device is substantially equivalent to a device that Is already cleared by the FDA. A 510(k) submission should include detailed technical, safety, and performance information about your medical device.
|Device Classification||Risk||Regulatory Controls||FDA Submission/Application Type|
|Class I||Low to Moderate||General||
510(k) Premarket Notification
*Majority of devices in this class are exempt from 510(k)
|Class II||Moderate to High||General and Special||510(k) Premarket Notification|
|Class III||High||General and Premarket Approval (PMA)||Premarket Approval (PMA)|
Differences Between FDA Medical Device Classes
Class I Devices
Class I devices pose a low to moderate risk to patients and/or intended users. Today almost 50% of medical devices fall into the Class I category. Devices in this category are subject to general regulatory controls; however, a majority are exempt from 510(k) premarket notification, and FDA clearance is not required before selling these devices in the United States. Examples of Class I devices include bandages, disposable gloves, tongue depressors, medical thermometers, and stethoscopes.
Class II Devices
Class II devices pose a moderate to high risk to patients and/or intended users. Today over 40% of medical devices fall into the Class II category. Devices in this category are subject to both general and special regulatory controls, and a majority require a 510(k) premarket notification to obtain FDA clearance. Examples of Class II devices include catheters, syringes, contact lenses, and pregnancy test kits.
Class III Devices
Class III devices pose a high risk to patients and/or intended users. Only 10% of medical devices fit into this category. Class III devices are subject to an application for PMA which requires extensive clinical data to support their safety and effectiveness. These devices typically help sustain or support life and can also be implanted. Examples of Class III devices include defibrillators, pacemakers, breast implants, and implanted prosthetics.
Steps for Classifying Your Medical Device
Within the FDA classification system, there are 1,700 generic types of devices that are grouped into 16 different medical panels or specialties (i.e., CFR Title 21: Parts 862 to 892). The devices are then assigned one of the three regulatory classes (i.e., Class I, II, or III) based on the risk and level of controls needed to ensure device safety and effectiveness. The FDA has put a system in place to help guide medical device manufacturers to the right classification. With this in mind, here are the appropriate steps to follow.
- Establish the intended use and indications for use of your medical device
Before attempting to classify your medical device, it is good practice to develop general statements regarding its intended use and indications for use.
- Select the FDA medical specialty and associated regulation(s) that best apply to your medical device
Once you have established the intended use and indications for use, identify the FDA medical specialty that best applies to your device. These specialties are listed in CFR Title 21: Parts 862 to 892.
- Find the FDA product codes that are applicable to your medical device
Once you’ve identified the applicable regulations for your device, you will need to identify the applicable product codes by conducting a search in the FDA Product Classification database.
For example, if “Neurological devices” is the best fit for your device, you would click on 882 Neurological devices to obtain a detailed list of the regulations associated with this specialty (see below).
In this example, if “Neurological Surgical Devices > Ventricular catheter” is identified as a possible fit for your device, you would click “882.4100 – Ventricular catheter” to retrieve information pertaining to this regulation (see below).
From here, you can determine if the regulation aligns with the intended use and indications for use of your device.
Next, you can select any additional regulations from the list that might align with your device and note the ones that best apply.
Here, you can enter the regulation numbers that were identified from Step 2 and click the Search button. You will need to conduct a separate search for each regulation number.
Using the example from Step 2, if you enter “882.4100” in the Regulation Number field and click the Search button, you will get a series of product codes and corresponding device classifications as shown below.
From here, you can click the links for each product code to determine the option that best applies to your device. Each product code will provide further details regarding the device regulation, including the type of FDA submission/application that is needed (e.g., 510(k)). In this example, if you click on the “HCA – Catheter Ventricular” code, you will see the details as shown below.
This process may seem overwhelming and may take some time. However, it is important to carefully review the different regulations and product codes to ensure that you choose the correct classification for your device. This will save you a lot of time and help you avoid costly mistakes in the long run.
In lieu of Steps 2 and 3, you can also determine your classification by searching for a device that is already cleared or approved by the FDA and substantially equivalent to yours in terms of intended use and indications for use.
- Search for similar device by clearance or approval
Using the FDA 510(k) Premarket Notification database, you can search for the device via 510(k) Number, Applicant/Manufacturer Name, or Device Name. This will provide the classification designation for the product that is similar to your device.
Using the FDA Premarket Approval (PMA) database, you can search for the device via PMA Number, Applicant/Manufacturer Name, or Device Name. This will also provide the classification designation for the product that is similar to yours.
- Search for similar device by device listing
As part of the FDA classification system (general controls), all manufacturers currently marketing a medical device must be registered and list their device. Using the Establishment Registration & Device Listing database, you can search for the Establishment/Company or Trade Name. This will provide the associated medical device and its classification.
Once you have identified your device classification, you can determine the necessary path for obtaining FDA approval and bringing your product to market.