Medical Devices | Device Classification

There are three regulatory medical device classes or medical device classifications established by the Food Drug and Cosmetic Act (FDCA) and FDA regulations. The medical device classifications are based upon the risks the device poses to the patient and the user or, alternatively, based on the level of controls that may be necessary to ensure the device can be operated safely and effectively.

Medical device classification depends on the intended use of the device and its indications for use. In addition, classification is risk based; that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Class 1 includes devices with the lowest risk and Class 3 includes those with the greatest risk.

Class 1 medical devices represent the lowest level risks to the patient or user. Most Class 1 medical devices can enter the U.S. market simply by ensuring the medical device labeling complies with the FDA regulations (including the regulations that apply specifically to the particular device); registering the device manufacturer and other companies in the supply chain with FDA; and listing the device with FDA. Some Class 1 medical devices also require Pre-Market Notification (PMN) or FDA 510(k) clearance, but most do not.

Class 2 medical devices carry greater patient or user risks than Class 1 devices. Class 2 devices are moderate risk devices because a failure or defect would present some level of harm or injury, but not serious injury and almost certainly not death. More than half of all Class 2 medical devices are subject to the PMN or FDA 510(k) clearance process.

Class 3 medical devices carry the greatest risk of the three device classifications. Failures or defects associated with Class 3 medical devices would pose significant risk of serious injury or even death to the patient or the user.

Medical device classification is performed by FDA based upon its own criteria. However, companies can still have some participation in the device classification process. Medical devices which are already subject to an FDA classification regulation ordinarily stay within that FDA classification. Devices that FDA has placed in one classification regulation, however, can be moved to another (more favorable) classification if the manufacturer can present to FDA the evidence and arguments to support reclassification.

FDAImports.com, LLC successfully reclassifies medical devices for its clients. Not all devices can be reclassified, because the FDA still governs the process and holds all of the cards. However, a well-argued proposal based upon knowledge of what FDA cares about can make it increasingly more likely that a reclassification request will be successful. FDAImports.com, LLC forges The Way Through for its clients in the medical device reclassification process.

As medical technology advances, new medical devices more frequently fail to clearly fit within existing medical device categories. FDAImports.com, LLC assists medical device manufacturers, distributors and importers in performing proper medical device classifications for their new devices. This is particularly important where it is necessary to convince FDA that the regulatory oversight for a new medical device should be the FDA 510(k) or PMN clearance process rather than a Class 3 Pre-Market Approval.

FDAImports.com, LLC has former FDA medical device reviewers and FDA expertise to apply to your medical device classification, your FDA 510(k) or PMN and your medical device PMA process. Finding The Way Through FDA medical device classification and FDA medical device clearance and FDA approval is important for successfully entering the U.S. medical device marketplace.