The Different Classes of Medical Devices

How does the FDA regulate medical devices?

The US Food and Drug Administration (FDA) regulates medical devices by classifying them into three categories determined by their level of risk to patients, Class I, Class II, or Class III. Even after a device is on the market, the FDA checks through post-market monitoring programs to recognize and address all safety issues. Medical device manufacturers are also expected to report product issues or adverse incidents to the FDA so that the agency can decide to take action that may include recalls or enforcement for the benefit of the public.  

Medical Device Concept to Market Process

Concept and Design 

The conceptualization and design of the medical device undergo prototyping and testing to improve the product. Development engineers observe the stages of medical device development, follow regulatory requirements, and have concise documentation of their work.  

Preclinical Testing   

Medical devices undergo preclinical testing with animal testing or in the laboratory to establish their effectiveness and safety before being tested on humans. Preclinical testing intends to gather data in support of the safety of the medical device.  

Investigational Device Exemption (IDE)   

A device manufacturer must obtain an Investigational Device Exemption from the FDA to conduct medical device clinical trials. The IDE application includes preclinical testing data and a detailed clinical trial plan.  

Clinical Trials  

A clinical trial aims to test device safety and efficiency for humans. Typically, clinical trials usually consist of three phases, each phase with an increase in participants and scrutiny level. Phase III trials are the most comprehensive, ranging from hundreds to thousands of participants.  

Review  

Depending on the classification of medical devices, the manufacturer applies to the FDA for premarket approval (PMA) or 510(k) clearance. The PMA application requisites include extensive data and evidence of an effective and safe product. The 510(k) clearance demonstrates that the device is equivalent to a previously approved medical device. The product code ascribed to a device is based on the classification and includes a description of the device.  

Postmarket Surveillance  

A medical device manufacturer continues to monitor for safety and effectiveness once a product is on the market. Monitoring of adverse events, implementing post-approval studies, and reporting to the FDA any issues are ongoing postmarket activities.  

Ongoing Maintenance  

Compliance with FDA regulations is an ongoing maintenance that may include inspections, reporting requirements, and quality control procedures. Medical device manufacturers must ensure their systems are working to their intended effects.  

What are the Different Medical Device Classes?

The FDA requires manufacturers to submit a pre-market notification or a pre-market approval application (PMA) before marketing their medical device. The medical device classes and pre-market review is based on the risk level associated with the device.  

The 3 Classes of Medical Devices  

• Low-risk Class I devices are subject to general controls like FDA registration, labeling requirements, and adhering to good manufacturing practices. Non-electric wheelchairs, bandages, and stethoscopes are examples of class I medical devices.  
• Moderate-risk Class II devices necessitate specific controls to ensure efficiency and safety. Controls may include performance standards, labeling requirements, and post-market surveillance. Powered wheelchairs, syringes, and catheters are class II medical device examples.  
• High-risk Class III devices require a thorough review process. They may include life-sustaining or life-supporting devices, implantable devices, and devices that pose a more considerable risk of injury or illness. Implanted prosthetics, pacemakers, and cardiovascular sutures are examples of class III medical devices.  

The different classes of medical devices may have differing review processes to accommodate their difference in patient risk. Manufacturers for Class I and II are medical devices that submit a pre-market notification to prove their device is equivalent to a predicate device already legally marketed and poses no risks to patients. Class III and some high-risk Class II devices submit a pre-market approval application (PMA) to the FDA. PMAs undergo a more intensive review process involving clinical trials and data to show device effectiveness and safety. 

The Importance of FDA Regulations for Medical Devices 

FDA regulations are pivotal in ensuring the efficiency and safety of medical devices. The potential of risking harm to patients if the product is improperly designed, manufactured, or used requires thorough testing. Manufacturers must provide documentation that the device works to its intended use and commit to continuous monitoring. Medical devices must also be transparent on potential risks and side effects so that patients can make informed decisions. Strict quality control regulated by the FDA establishes a standard of consistency and effectiveness across all products. Having clear regulatory guidelines and a stable environment promotes the advancement and innovation of medical technologies.  

Medical Device Validation and Testing Services 

Benefit from third-party objectivity when committing to medical device compliance. Medical device testing to meet regulatory standards requires the expertise of an industry leader. Arbour Group helps organizations worldwide deliver on compliance through core competencies, including software validation, policies & procedural controls, and quality agreements. Our compliance experts ensure that your medical device meets the rigorous requirements of FDA 21 CFR Part 11 and other regulatory demands. Contact us to learn the benefits of medical device compliance with Arbour Group.