Understanding the FDA Medical Device Classification System

The world of medical devices is one of the most varied and complex industries around today. Innovations to research and development, data collection, and computing have all expanded the reach and impact a device can have.

But along with those advancements, there also comes a need for new systems and processes to support everyone involved throughout the supply chain, from engineer to designer, from sales rep to purchaser, and from doctor to patient. After all, quality control is more than a department, especially when patients’ lives are in our hands. That’s why every single medical device created or sold in the United States undergoes product classification from the FDA.

Understanding your product’s classification can be hugely beneficial for several reasons:

  • Better estimate how long to expect premarket process to take

  • See a clearer picture of how much it will cost to bring your product to market

  • Design and develop a safe and effective product with clear requirements

But what exactly does that medical device classification process from FDA look like, especially with the expanding medtech industry? Let's take a look inside the FDA classification system for medical devices, so you can understand the steps involved and the regulatory expectations you must meet to bring your device to market.

FREE DOWNLOAD: Click here to download the eBook of our step-by-step guide to determine how your medical device will be classified.

How medical devices are classified by FDA

The FDA Center for Devices and Radiological Health (CDRH) is tasked with reviewing, evaluating, and affirming the quality of any proposed medical product before it goes to market. To put structure around this process, FDA developed a classification system for assessing potential risk and subsequent regulatory efforts to ensure quality standards are met.

 

Device class

FDA divides medical devices into three groups, Class I, Class II, and Class III. The ranking is based primarily on the level of risk posed to the end user. Each class level carries a different set of regulations and requirements; the higher the class, the higher the risk.

FDA classifications are based directly on two distinctions: the intended use and the indications of use. Though they might seem interchangeable, they carry completely different meanings and involve two distinct processes.

  • The intended use is what you claim your device does, or its general function. For instance, a scalpel’s intended use is to cut tissue. 

  • The indications for use illustrates the conditions or reasons under which the device will be used.

Wording these statements takes careful consideration and may require a few rounds of input from your teams. Remember, the FDA risk-based classification will determine the regulatory requirements for your device; if the words get jumbled or you say too much, it may result in a higher classification than previously expected.

 

Regulatory controls

With a risk-based classification system, FDA defines what level of regulatory control is necessary to ensure the product is safe and effective. The three levels of regulatory controls are as follows:

  • General Controls are the most basic and unobtrusive requirements for a medical device. 

  • Special Controls can extend to standards of device performance, patient registries, special labeling requirements, and even future surveillance after a product is released into the market. It will also require the filing of complex forms like 510(k), which requires a, “demonstration of substantial equivalence to another legally U.S. marketed device.

  • Premarket Approval is the most stringent set of regulatory controls. In it, manufacturers are subject to lengthy in-depth reviews from the agency, as well as panel reviews of any relevant data or scientific arguments. The average PMA application review time is 243 days, or just over 8 months.

 

Classification regulations

With over 1,700 distinct types of medical devices to sort through, additional classification regulations from FDA like the ones found in Title 21 of the Code of Federal Regulations (CFR) can be a big help. The regulations group all devices into one of 16 medical specialty panels, such as cardiovascular, ear nose and throat, dental, or radiology.

Researching your classification regulations is a fairly straightforward process. On the FDA database, you’ll find a full list  of all medical speciality panels. Once you find the correct class regulation that fits, you’ll be taken to another listing of all relevant regulations for that group. Once you’ve determined which regulations apply, you’ll be given specific instructions and requirements for that device.

Classification regulations are significant for not only making content research easier, but additionally for anyone in product design or quality. Much like with knowing your device class, being aware of the resources that are available can help you build a safer, more effective device with less down time during the classification and premarket processes.

 

What’s next after determining device class?

After you’ve determined the class of your medical device, you’ll need to review the necessary regulatory controls issued for the product. These are assigned based on the classification of the device. Let’s review those classifications once more:

Class I: (Low to Moderate risk) General Controls

Class II: (Moderate to High risk) General Controls and Special Controls
Class III: (High risk) General Controls and Premarket Approval (PMA)

For those with devices in Class I, the road forward will be much faster and straightforward. For those in Class II, it may be time to return to the drawing board to modify, add, or remove elements of the original design. Pay special attention to the regulatory fine print, as these documents should spell out the requirements for manufacturers. 

Finally, if you’re in Class III, there is a much more earnest and thorough process awaiting you known as a Premarket Approval (PMA) process.

FREE DOWNLOAD: Click here to download the eBook of our step-by-step guide to determine how your medical device will be classified.

How Greenlight Guru can help you successfully market your medical device in the US

At Greenlight Guru, we are all about helping medical device companies find their next win. The medical device industry is appealing financially, sure, but it can be very daunting. So, why go at it alone when you can implement a solution built specifically to meet the unique needs of the medical device industry?

The Greenlight Guru Medical Device Success Platform (MDSP) is the only QMS software designed specifically for medical device companies, such as yours. Whether it’s a complete teardown, or just a few simple corrections before release, our solution and in-house team of industry experts, also known as Gurus, are ready to help you navigate the FDA classification process with ease so you can bring safe, high quality devices to market faster.

To learn more, get your free demo now →


Looking for a design control solution to help you bring safer medical devices to market faster with less risk? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software