The FDA has established medical device classes for 1,700 different types of devices, grouped them into 16 distinct risk categories, and assigned each category a rating of Class I, Class II, or Class III, each with varying regulatory requirements. The purpose of the classification system is simple: to ensure the appropriate safeguards are applied to devices that carry greater risk, and to accelerate time to market for devices whose intended use and indications for use make them inherently safer.
Class I represents the lowest risk-class of medical devices. These devices, along with Class II and Class II devices, are subject to the lowest level of regulatory controls by the FDA, referred to as the general controls. These controls are authorized under the following sections of the Federal Food, Drug and Cosmetic Act:
In 21 CFR Part 820, where the FDA outlines its quality system requirements for medical device companies, Class I devices are exempt from certain quality systems activities. Manufacturers are not required to establish and document design controls for Class I medical devices.
Medical devices fall into Class II if it can be determined that the general control provisions outlined above are insufficient to provide a reasonable assurance of the safety and effectiveness of the device for the end user. Class II medical devices are subject to all of the same general controls as Class I devices, along with added special controls, which include performance standards, post-market surveillance, development of guidance documents including 510(k) submissions (here's everything you need to know about 510(k) submissions) and other requirements.
Organizing your documentation for a 510(k) submission is far from being a straightforward process - that's why up to 75% of medical device companies have their first submission rejected (more on How to Avoid 510(k) Submission Rejection here). Using Greenlight Guru quality management system will help you organize your documentation to ensure a successful 510(k) submission and the shortest possible time to market. We even wrote the Ultimate Guide on 510(k) Submission to help get you started.
Devices in Class III are subject to the same general and special controls as Class I and II devices. The defining attribute of Class II devices is that they are life-supporting or life-sustaining in their application, or their use is of substantial importance in preventing impairment of human health, or their use prevents a potential unreasonable risk of illness or injury.
As such, all Class III medical devices require pre-market approval in accordance with section 515 of the Federal Food, Drug, and Cosmetics Act.
When you've got an idea for a new medical device that you're planning to put into action, determining how your medical device will be classified is one of the first things you should do. You can figure it out quickly by viewing our step-by-step guide to medical device classification. Device classification determines your path to market, helping you plan your QMS compliance initiatives and organization to meet the specific requirements of your device.