Did you know that classifying your medical device incorrectly could extend the Food and Drug Administration's (FDA) approval process by months?
As many medical device manufacturers know too well, risk classification is a major undertaking. Knowing the correct classification of your medical device can help to ensure a smooth Premarket Notification (510k) and Premarket Approval (PMA) process.
So, what can your organization do right now to guarantee seamless and appropriate risk classification? Let's take a look.
Understanding Risk Classification of Medical Devices: 3 Major Grades
To correctly classify your device and guarantee a simple pre-market approval process, we recommend partnering with an eQMS provider.
You see, paper-based quality management systems are a thing of the past. To better adhere to new and evolving regulations, many industry-leading medical device manufacturers have upgraded their legacy, paper-based systems, and moved to electronic quality management systems. As a result, organizations can systematize and document quality-related processes instead of approaching them on an ad hoc basis.
For the best results, we recommend taking the time to better understand the three major grades of risk classification for medical devices.
1. Class I (Low)
Class I devices are "not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury," according to the FDA.
This is the most common type of device classification, accounting for more than 47 percent of approved devices currently available on the market today. These devices are subject to the fewest regulatory requirements and restrictions.
However, Class I devices still must adhere to a few general provisions, including adulteration, branding, device registration, records, and good manufacturing practices. Additionally, Class I devices are required to implement a quality management system to ensure that the product is well-designed and safe for use.
2. Class II (Medium)
Class II devices present a higher risk category than Class I devices. The FDA defines Class II devices as "devices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device."
For Class II devices, controls vary depending on the device. However, common controls include device performance, post-market surveillance, patient registries, special labeling requirements, premarket data requirements, and guidelines. In most cases, Class II devices are approved through the Premarket Notification or 510(k) process. The 510(k) is a complex application to the FDA, which proves that a device is safe and effective by demonstrating that the device is equivalent to another device currently available on the market.
The FDA released an exemption list in early 2018, which exempts over 800 generic Class I and II medical devices from the 510(k) process. If you have a generic Class II medical device, you can discover whether it is exempt from a 510(k) filing by searching the FDA Product Classification database.
3. Class III (High)
According to the FDA, Class III devices "usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and break implants. 10% of medical devices fall under this category." For this reason, Class III devices are the most highly regulated.
While Class III is generally reserved for the most innovative and cutting-edge medical devices, other devices can fall into Class III for different reasons. Some devices that are initially categorized as Class II may be bumped up to Class III if the manufacturer is unable to demonstrate substantial equivalence to a predicate (i.e., an existing product) during the PMA (510k) filing process.
The PMA process requires a rigorous study of the medical device to prove safety and effectiveness through the development of a data-driven benefit/risk profile. The PMA process generally involves clinical trials and significant time and resources for sufficient data collection.
Understanding Risk Classification of Medical Devices
You can significantly streamline the path to market approval by understanding the risk classification of your medical device. Moreover, if your organization is subject to Class II or Class III 510(k) or PMA requirements, this knowledge can help you to identify the appropriate resources required for filing.
In this pursuit, we recommend investing in an electronic quality management system. Sign up for one of our daily eQMS demonstrations based on your unique industry to see the platform in action. You'll also be able to ask any questions to find out whether Qualio is the best fit for your needs.