Medical device classification guides the regulatory process for all reusable medical devices in the United States. You must understand what class it falls under and what that means for your approval process if you want to bring a new product to the market. Learn more about the classification process of medical devices in the United States and explore the different approval requirements with this guide.
What Are Medical Device Classifications?
Medical device classification is a system of regulatory classes that defines the risk—and, therefore, the rules—surrounding specific medical devices. The level of danger associated with a device determines its classification. The higher the risk, the higher the level of regulatory control necessary before and after your device hits the market.
Therefore, a device’s classification determines what you must do to gain market approval and sell your product. This approval process includes the requirements you need to meet during development, the necessary design controls of a device, and even how much time and money it will take to bring your device to market. Understanding which class your device falls under outlines your regulatory pathway and helps guide your path to market approval.
Classifications in the United States
Different countries follow different guidelines when classifying medical devices. You must adhere to the classification system of the Food and Drug Administration (FDA) if you want to manufacture and approve a product for markets in the United States. The Center for Devices and Radiological Health (CDRH) is the specific branch of the FDA that regulates medical device classification to ensure medical devices are safe for the market. The FDA and the CDRH divide medical devices into three categories based on their level of risk: Class I, Class II, and Class III.
Class I Medical Devices
Class I medical devices offer the lowest risk for patients. These types of devices are non-critical and have a low chance of causing contamination. They encounter skin cells, but they do not penetrate the skin or the body, which means they have a low risk of interacting with bodily fluids and other soils. Examples of Class I devices include stethoscopes, skin electrodes, blood-pressure cuffs, and reusable bedpans.
Class II Medical Devices
Class II medical devices offer a moderate to high level of risk for patients. These devices are semi-critical and generally have longer periods of contact with the body. They might also encounter microbial surfaces and materials, such as broken skin. However, they do not interact with internal tissues, resulting in a moderate risk of contamination. Class II reusable medical devices include tools such as endoscopes, laryngoscopes, and anesthesia equipment.
Class III Medical Devices
Class III devices have the highest level of risk. These medical devices are critical for medical treatment. They come into direct contact with the bloodstream, internal tissues, and other sensitive internal body parts. This direct contact leads to higher chances of contamination or infection. This contact, combined with the fact that Class III devices encounter the most sensitive and critical parts of the body, calls for stringent regulatory requirements. Examples of Class III medical devices include scalpels, clamps, implants, catheters, and biopsy instruments.
Intended Use and Indications for Use
The classification process of medical devices in the United States revolves around the intended use and the indications for use of the device. Intended use refers to the general purpose of the medical device. Indications for use refer to the disease or condition that the device addresses through diagnosis, treatment, or prevention. Indications for use also describe the target patient.
Together, intended use and indications for use define the reason why you designed your reusable medical device in the first place.
Finding the FDA Regulation
Once you know your intended use and indications for use, the next step is to find the possible regulatory classification for your product via the FDA. The FDA keeps a database of 16 categories based on general medical specialties. Within each category are dozens of specific device regulations. Once you find a regulation that aligns with the intended use and indications for use of your device, you can find the class of your device.
Finding the FDA Product Code
You must use the FDA Product Classification Database to find the right code for your device after finding its regulation and classification. Input the regulation number to obtain a list of possible product codes. Review each option to find the one that best fits your reusable medical device.
The Pathway to Approval
Once you know the regulation, product code, and classification, you will also have the regulatory controls you need to follow to obtain market approval.
Class I: General Controls
Most Class I medical devices only require general controls. All medical devices must meet these FDA requirements for approval for the US market. They cover adulteration of devices, device misbranding, device registration, banned devices, notification and other remedies, records and reports, and general provisions.
Class II: General Controls and Special Controls
Class II devices need the same general controls and special controls. Special controls are device-specific factors, such as performance standards, post-market surveillance, patient registries, specific labeling requirements, premarket data requirements, and device guidelines.
Class III: General Controls and Premarket Approval
Class III devices require general controls and a premarket approval (PMA) process. Therefore, you must submit a PMA application and gain FDA approval before marketing your device. This application should consist of a comprehensive device description, the device’s indications for use, any relevant performance standards, and the methods, facilities, and controls used during manufacturing, processing, packaging, and storing processes. It should also include a bibliography of all published reports and copies of the proposed labeling, financial certifications, and disclosures from clinical investigators.
Finally, the PMA contains two technical sections that revolve around pre-clinical and clinical studies. One should detail the results of non-clinical laboratory studies, such as microbiological, toxicological, biocompatibility, shelf life, and other laboratory tests. The other details are the results of clinical investigations involving human subjects.
Product Exemptions
Certain devices might be exempt from specific approval requirements. Therefore, most Class I devices and many Class II devices are exempt from premarket notification requirements (generally known as a 510(k) submission). Some devices are also exempt from current Device Good Manufacturing Practices (GMP).
However, these exemptions do not affect other requirements, such as the FDA’s general controls. Understanding what your device is and isn’t exempt from helps you streamline the approval process while still providing reasonable assurance of your device’s safety and efficacy.
Medical Device Testing Services You Can Trust
Partnering with services you can trust when navigating the regulatory pathway for your medical device is crucial. Highpower Labs has decades of experience in medical equipment testing. Let us help you streamline your testing and validation processes. Contact our team today to learn more about how our expertise can serve you.