Medical device classification is a critical element of the product development process for medical technology companies. It’s worthy of more attention than a one-time review by an FDA regulatory expert. Why?
Because the FDA classification of your new medical device determines your pathway to market:
- FDA clearance through a 510(k) submission
- FDA approval through the Premarket Approval (PMA) process
- Designation as a Class I or II device through an FDA-granted De Novo submission
Devices in the following categories are treated differently:
- Not a device: After defining the intended use and indications for use for your new medical technology, you may find that it does not meet the FDA’s definition of a medical device and is, therefore, not subject to the FDA clearance process.
- Enforcement discretion: The FDA can exercise its authority to waive some regulations when it determines that (1) there is a valid reason to do so (e.g., a public health emergency like the Covid-19 pandemic), and (2) risk to consumers is low.
- 510(k) exempt: Some Class I and II devices are exempt from the 510(k) process because substantial equivalence is not necessary to prove their safety and effectiveness. Such devices may still be subject to the FDA’s good manufacturing practices (GMPs).
The FDA’s medical device classifications are governed by amendments to the Food, Drug, and Cosmetic Act passed in 1976. The medical device classifications fall under sixteen broad medical specialties (“panels,” in FDA jargon). Under these sixteen panels, the FDA recognizes 1,700 generic device types. Each device type belongs to an FDA regulatory class, and each regulatory class places specific requirements on medical device manufacturers.
|Class||Risk level||Typical regulatory controls||Typical premarket process (exceptions are common)|
|Class I||Low||General controls||510(k) exempt|
|Class II||Medium||General controls + special controls||510(k)|
|Class III||High||General controls + special controls||PMA|
The goal of FDA medical device regulations is to ensure the safety and efficacy of new medical technology. The higher the risk a device poses to users, the more stringent the regulatory pathway it must navigate.
- Class I devices pose little risk to users. They are often exempt from the 510(k) and PMA processes but are subject to the FDA’s general controls, which include rules related to records, reports, restricted use, and good manufacturing practices (GMPs).
- Class II devices present a higher risk to users than Class I devices. They are usually subject to the FDA’s general and special controls. Special controls vary depending on the device type, but include performance standards, labeling requirements, and premarket data requirements, among other things. Class II devices usually also require FDA clearance through a 510(k) submission. The purpose of a 510(k) is to ensure a new device’s safety and effectiveness by demonstrating that it’s substantially equivalent to a preexisting, legally marketed device (known as a predicate device).
- Class III devices, as defined by U.S. law, are given this classification because they’re used to “support or sustain human life” or “present a potential, unreasonable risk of illness or injury.” Consequently, they’re usually subject to general controls, special controls, and the FDA’s rigorous PMA process.
Devices that do not fit into an existing device type and regulatory class are automatically considered Class III devices unless they are reclassified into Class I or II through a De Novo request.
in2being created a free tool to assist with device classification research called PathSurveyor. In addition, the FDA provides several resources you can use to research which device type and medical device classification fit your medical device.
- Search the FDA product classification database.
- Browse the FDA medical device classification panels.
- Seek feedback from the FDA on your classification through a 513(g) submission.
The classification of your new medical device means everything in determining your regulatory roadmap. in2being specializes in guiding medical technology companies through every aspect of bringing a new medical device to market. Contact us to find out more about our services.For a more detailed look at medical device classification, watch MedTech Crossroads Episode 23, “FDA Registration, Listing, Clearance, Granting, Approval… Oh my!”
Medical device startups speak of having a “regulatory roadmap.” Unfortunately, this critical step is often treated as a one-time, static analysis completed by a “regulatory expert” rather than an interactive resource that is understood by the development team. The FDA freely provides the databases to perform such roadmap analyses. Having a knowledgeable person review and confirm your analysis is important, but a regulatory roadmap is something your company must own, master, and live with throughout the development process.
To classify your medical device and start to understand its regulatory roadmap, it helps to know that FDA has grouped some 1700 generic device types into 16 medical “panels.” For example, certain patient monitors are in the “general hospital” panel, while a pulse oximeter is classified under the “cardiovascular” panel. Placing yourself into the correct “bin,” either informally or formally through the 510(k) substantial equivalence process, is at the heart of the primary FDA regulatory process.
Additionally, it’s important to know that FDA classifies devices into one of three regulatory classes: class I, class II, and class III. These classes are based on product risk.
All classes of devices require the application of “general controls” that were established in 1976 as amendments to the Food, Drug, and Cosmetic (FD&C) Act. They contain requirements concerning adulteration; misbranding; device registration and listing; premarket notification (submission of 510(k) application for “substantial equivalence”); banned devices; notification; repair, replacement, and refund; records and reports; restricted devices (prescription use); and good manufacturing practices (otherwise known as QSR, cGMP, or just GMP).
Depending on the specific device, parts of general controls may be exempted. For example, many class I devices are exempt from GMP, creating an easier pathway.
Many class II devices require “special controls” in addition to general controls. These ensure safety and efficacy when general controls alone are insufficient. As the FDA says, “Special controls are usually device-specific and include: Performance standards, Postmarket surveillance, Patient registries, Special labeling requirements, Premarket data requirements, and Guidelines.”
Finally, class III devices normally require a pre-market approval (PMA) submission to FDA in addition to general controls. PMAs are outside the scope of this video, but keep in mind that any company embarking on a class III development project has undertaken the highest level of FDA scrutiny and associated costs.
Sometimes, a novel device will not fit within the existing regulatory classifications, nor will it have a suitable predicate device for substantial equivalence. This device may require a De Novo submission (which is the subject for another video).
In order identify which panel, regulation number, and product code your device may fit under, along with associated regulatory requirements and exemptions, you can search the FDA classification database by keyword. You can also skim through the classification panels directly, looking for appropriate categories for your device.
And in2being’s Pathsurveyor tool brings many of these FDA resources together in a single search bar format. Pathsurveyor is a great tool for finding related devices and historic clearance times for 510(k) devices.
Ultimately, your goal is to narrow down to one or more product codes which adequately describe your device’s intended use. The FDA page for a specific product code lists the primary regulatory milestones, such as whether your device requires a 510(k) or GMP.
Sanity check your findings with someone knowledgeable in the regulatory space, and consider submitting a 513(g) Request for Classification directly to FDA for confirmation. Feel free to reach out to in2being for assistance in either of these areas.