Medical Device Classes Explained: What They Mean for Regulatory Approval

Wouldn’t you want to be sure that the pacemaker being implanted in your chest is held to a higher standard than the bandage covering your incision? So would we. Fortunately, the Food and Drug Administration (FDA), the leading authority in the U.S. medical device market, has established a system to ensure precisely that.

The FDA is responsible for determining not only whether a device is safe for human use but also whether it’s effective for its intended purpose. When bringing a new device to market, understanding its classification is crucial, as this determines the level of regulatory scrutiny and approval required.

Here are the 3 classes of devices and how the FDA validates that they are safe and effective.

Class I

Class I medical devices are the simplest and present the lowest risk to patients and users. These devices are generally designed for basic, non-invasive procedures and are commonly used in various healthcare settings. The FDA defines Class I devices as:

“Devices that pose minimal potential harm to the user and are often simple in design.”

Examples of Class I Medical Devices:

• Bandages
• Examination gloves
• Handheld surgical instruments
• Stethoscopes
• Manual toothbrushes

Regulatory Pathway for Class I Devices: Class I devices are subject to the least regulatory control. Most of these devices are exempt from the FDA’s premarket notification (510(k)) process, meaning manufacturers do not need to submit extensive data to demonstrate safety and effectiveness. Instead, manufacturers must comply with general controls, which include requirements for proper labeling, registration with the FDA, and adherence to good manufacturing practices.

Despite the lower regulatory burden, manufacturers of Class I devices must ensure that their products are safe for use and meet all applicable standards. About 47% of medical devices fall under this category, reflecting the large number of simple, low-risk products that are essential in everyday healthcare.

Class II

Technology that falls under Class II is more complex and carries a moderate risk compared to Class I devices. These devices are often essential in medical settings, but they do not usually support or sustain life. The FDA defines Class II devices as:

“Devices that require more regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. These devices generally present a moderate risk to the patient.”

Class II devices often have a greater impact on patient health and may be intended for more long-term use. As a result, they require a higher level of scrutiny, including additional regulatory controls such as special labeling requirements, mandatory performance standards, and post-market surveillance.

Examples of Class II Medical Devices:

• Powered Wheelchairs
• Surgical Drills
• Blood Pressure Monitors
• Catheters
• Contact Lenses
• Digital Thermometers

Regulatory Pathway for Class II Devices

Unlike Class I devices, which are largely exempt from premarket submissions, Class II devices usually require a 510(k) submission to the FDA. This premarket notification process ensures that the device is safe and effective by demonstrating that it is substantially equivalent to an existing device. Approximately 43% of medical devices fall under this category, and most must undergo this submission process to be legally marketed.

While Class II devices do not typically require the more stringent premarket approval (PMA) process the 510(k) process involves rigorous testing and documentation to prove safety and effectiveness. And in some cases if similarity to a predicate device cannot be proven, a Premarket Approval is required. 

Class III

Class III medical devices are the most complex and carry the highest risk to patient safety. These devices are often life-sustaining, life-supporting, or implanted, and therefore, require the strictest regulatory controls. The FDA defines Class III devices as:

“Devices that usually sustain or support life, are implanted, or present a potential unreasonable risk of illness or injury”

Class III devices undergo the most rigorous scrutiny by the FDA due to the potential risks they pose. They often are cutting-edge medical technology, with the potential to save or significantly improve lives.

Examples of Class III Medical Devices:

• Implantable Pacemakers
• Heart Valves
• Implantable Defibrillators
• Cochlear Implants
• Deep Brain Stimulators

Regulatory Pathway for Class III Devices

Unlike Class I & II devices, Class III devices are almost always required to go through the premarket approval (PMA) process. The PMA process is the most rigorous type of application required by the FDA. It involves a thorough review of clinical data to support the device’s safety and effectiveness.

• Premarket Approval (PMA): The PMA process requires manufacturers to submit extensive clinical trial data, technical specifications, and detailed reports on the device’s design, manufacturing, and testing processes. The FDA rigorously reviews this data to ensure the device meets the necessary safety and efficacy standards.
• Post-Market Surveillance: Even after approval, Class III devices are often subject to post-market surveillance to monitor their long-term safety and effectiveness. This may include mandatory reporting of adverse events, additional studies, and ongoing regulatory oversight.

In many cases additional submissions may be required even years after approval. This would occur in the case of new indications of use, significant device modifications or emerging safety concerns that would warrant new studies to reassess the device as safe and effective. 

Nextern has become an industry leader in the medical device development process and getting medical devices through regulatory approval to market. With a global presence in Minnesota, Vietnam, Costa Rica and China, we collaborate with partners to bring their ideas to market. If you are ready to bring your device to market, Contact us to begin developing your next great device idea!