Medical Devices | Device Classification

Medical device classification depends on the intended use of the device and its indications for use. It also based upon the risks the device poses to the patient and the user and level of controls that may be necessary to ensure the device can be operated safely and effectively. There are three regulatory medical device classes or medical device classifications established by the Food Drug and Cosmetic Act (FDCA) and FDA regulations.

Class 1 medical devices represent the lowest level of risk to the patient or user. Most Class 1 medical devices can enter the U.S. market by ensuring that the device labeling complies with FDA regulations (including the regulations that apply specifically to the device); registering the device manufacturer and other establishments in the supply chain and listing the device with FDA.

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 to the patient or user. More than half of all Class 2 medical devices are subject to the 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.

Devices that FDA has placed in one classification regulation may be moved to another (more favorable) classification if the manufacturer can present to FDA evidence and arguments to support reclassification. FDAImports.com, LLC has successfully petitioned FDA to reclassify medical devices for its clients.

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 510(k) clearance process rather than a Class 3 Premarket Approval.

FDAImports.com, LLC has former FDA medical device reviewers and FDA expertise to examine and determine your medical device classification. Finding The Way Through FDA medical device classification , medical device clearance and FDA approval is important for successfully entering the U.S. medical device marketplace.

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