Navigating the Current US FDA Medical Device Classification

For manufacturers looking to enter the US medical device market for the first time, the US FDA approach to device classification may be confusing to navigate. Where manufacturers are accustomed to rules-based approaches to classification like those established in current International Medical Device Regulators Forum (IMDRF) guidance (e.g. GHTF/SG1/N77:2012 and IMDRF/IVD WG/N64FINAL:2021) and in the EU under Annex VIII of the MDR/IVDR, the US FDA classification system approach may be daunting.

In this article, we cover US FDA device classification and cover methods manufacturers may use in determining the classification of their devices in the US market. Please note that this article covers products that a manufacturer has already determined are devices under the US FDA regulatory framework. 

The current US FDA medical device classification and its origins

The US FDA classifies medical devices as one of three classes based on their associated risks and the level of regulatory control the US FDA has determined necessary to assure a reasonable assurance of safety and effectiveness – Class I, II, or III. Class I devices have been determined by the regulator to pose the lowest risk to the patient and/or user, Class II devices have a moderate level of risk, while Class III devices pose the greatest risk. However, in contrast to a rules-based approach in determining device classification, the US FDA applies a prescriptive approach. 

This prescriptive approach has its origins on May 28, 1976, when the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) entered into force. At this time, any device in US commercial distribution before this date (referred to as “pre-amendment devices”) was classified as one of the three device classes (i.e. I, II, III) according to specific classification regulations. Over time, the number of specific classification regulations has been expanded under different medical specialty panels (21 CFR Parts 862 – 892) (see point 2 below) 

The individual classification regulations prescribe (among other information) the device class applicable to a specific type of device based upon its “intended use” and “indications for use”. The “intended use” of a device is its general purpose or function and includes the indications for use, whereas the “indications for use” describe the disease or condition a device will diagnose treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended. A good example of the difference between “intended use” and “indications for use” provided by the US FDA on its website is that for a scalpel. In this case, the intended use of a scalpel is to cut tissue, whereas an indication for use could be for making incisions in the cornea. 

Once a manufacturer has determined the appropriate classification regulation for their device, they must also determine the appropriate US FDA Product Code(s) for their device, as the FDA has assigned 3-letter product codes to specific types of devices that fall within the scope of specific classification regulations. For example, while classification regulation 21 CFR Part 870.2700 is for oximeters, at the time of this blog article there are 8 different product codes, including codes for reprocessed oximeters (NLF) and tissue saturation oximeters (MUD). Manufacturers can select more than one product code for their device, particularly in the case of systems, although these are always distinguished between primary and secondary codes. 

It should be noted that the Center for Biologics Evaluation and Research (CBER) regulates several devices licensed under the Public Health Services Act (e.g. blood donor screening tests) for which regulations outlined in 21 CFR Part 600 impact classification product codes too. 

When utilizing the tools/methods available to determine the US FDA classification for a device, manufacturers may encounter scenarios where a device is not assigned one of the three established devices (i.e. I, II, III) but is instead identified as being “unclassified” or “not-classified”. An “unclassified” device is a pre-amendment device for which a classification regulation has not been promulgated, whereas a “not-classified device” is a post-amendment device for which the US FDA has not yet reviewed a marketing application or not yet made a final decision on such a marketing application. 

Tools and methods for determining US FDA device classification

There are four tools/methods available for manufacturers to determine the classification of their device, including consultation of the following resources: 

1. FDA Product Classification Database 

This database includes both “Quick” and “Advanced” search capabilities and allows individuals to perform a search of the classification regulation and 3-letter product codes that have been assigned by the US FDA based upon keyword or feature searches, such as those indicated in the screenshot of the Advanced Search option below: 

For example, a search under “Device” using the keyword “catheter” yields 265 search results with an indication of the following for each search result: 

• • Product Code 
  • Device 
  • Regulation Number 
  • Device Class 

Selecting the “Device” brings up the content established under the corresponding Product Code while selecting the “Regulation Number” brings up the content of the specific classification regulation. For example, (As is shown below), clicking on “Kit, Balloon Repair, Catheter” which falls under the DQP product code from the “catheter” search described above yields the following information, including the classification of this device as a Class 3 (III) device (as established under classification regulation 21 CFR Part 870.1350). 

Likewise, clicking on the 870.1350 classification regulation listed for this specific search result brings up the following information for this regulation, which is applicable to all product codes that fall under this regulation. (A screenshot of the classification regulation determining catheter balloon repair kits are Class III devices is shown below). This tool/method is best used where manufacturers have not identified a similar device legally marketed in the US. 

2. FDA Device Classification Panels

The US FDA has divided its classification regulations across 19 different medical specialties referred to as classification panels. Some panels are more focused on in vitro diagnostic medical devices, such as “Chemistry”, “Hematology”, “Immunology”, “Microbiology”, “Pathology” and “Toxicology” while other panels are more focused on traditional medical devices (e.g. “General Hospital”). 

While it is possible to identify an appropriate classification regulation through this tool/method, it is not possible to identify potential product codes applicable to the device. Therefore, this tool/method is commonly used together with the product classification database described above, as the classification regulation can be utilized as a keyword in searches performed. 

3. Search for similar device marketing approvals and authorizations 

Where manufacturers are aware of a similar device that is already legally marketed in the US, several databases may be consulted depending upon the type of marketing approval/authorization obtained for the similar device. As these submissions require identification of device classification (regulation and product code), where available, the publicly available information on the FDA decisions includes this information. Particularly in the case of devices subject to the 510(k) pre-market authorization pathway, this can also be a means to identify potential “predicates” which are an essential component of such regulatory submissions. 

These databases also include both “Quick” and “Advanced” search capabilities and include the following: 

• • Pre-market Approval (PMA) Database 
  • 510(k) Pre-market Notification Database 
  • Device Classification Under Section 513(f)(2) (De Novo) Database 
  • Humanitarian Device Exemption (HDE) Database 

However, devices that are not subject to PMA or HDE, or are exempt from pre-market notification (most Class I and some Class II devices) may not be listed in the above databases which leaves the following tool/method for manufacturers of such devices. 

4. Search for similar device product listings

Under 21 CFR Part 807, all manufacturers (both domestic and foreign) must register their establishments and list their devices on an annual basis. The US FDA maintains an Establishment Registration and Device Listing database with both “Quick” and “Advanced” search capabilities (A screenshot of the “Advanced” search function is shown below). 

Therefore, where manufacturers are aware of specific similar Class I or II devices unable to be identified using the previous tools/methods, this database may be searched to identify the classification regulation and product code for the similar device. 

Options for manufacturers when the classification cannot be determined 

After considering and applying the tools/methods above, manufacturers may still be unable to definitively determine an appropriate classification regulation and product code (and subsequently class) for their device. In such cases, it is recommended that manufacturers submit a formal device classification request from the US FDA via a 513(g) Request for Information (RFI). The agency has published guidance on the preparation of such submissions, available here, and while user fees are applicable for such submissions, they are also eligible for reduction with an approved small business determination. 

Learn more about the US FDA device classification with MedEnvoy

This article provides an overview of the US device classification system under the FDA regulatory framework, however, if you have any questions about entering the US device market, including device classification, or require a US Agent, or require relevant training/consulting services, get in touch. 

Additional resources

• • US FDA Agent – MedEnvoy
  • FDA Final Guidance on Cybersecurity in Medical Devices
  • US Clearance for Medical Devices: FDA 510(k) Explained
  • What You Need to Know About FDA Q-Sub and Pre-Sub