Registering a medical device with the FDA requires specific determinations for the exact class in which a medical device belongs. If you are an owner or operator of an establishment or facility that produces and/or distributes medical devices, healthcare apps, or healthcare software for use in the United States, you are required to establish yourself by registering annually with the Food and Drug Administration (FDA). Any company that “diagnoses” a health condition and aims to treat it (through a device, mobile app or software application) must register. Here we’ll take a look at each medical device class, why registration is necessary, and how to properly classify your medical device.
What are Medical Device Classes?
There are three classes of medical device. This classification establishes the risk and the level of control needed to reasonably assure that the medical device is safe and effective for use. As a device increases in class, its regulatory controls increase as well. Class I requires general controls, Class II requires both general and special controls, and Class III requires both general controls as well as the requirement of Premarket Approval (PMA) before distribution.
General Controls – General controls apply to almost all medical devices—there are limited exemptions.
Special Controls – Special controls apply to devices in which general controls alone are not extensive enough to assure the safety and effectiveness of the medical device.
Premarket Approval – Premarket approval is reserved for devices that are used in supporting human life or preventing impairment of health. These devices are at risk of presenting an unreasonable chance of illness or injury. This stringent approval requires the applicant to receive FDA approval before marketing the device. The manufacturer must provide sufficient scientific evidence to assure the FDA that the device is both safe and effective for its intended use.
Why Registration is Necessary
Owners or operators of medical device establishments are required to register and list the devices they make and any activities performed on these devices prior to distribution.
The registration and listing process is not without its reasons. This process allows the FDA to log information about the location of establishments and facilities, and the devices they manufacture. With this information on deck, the nation can be better prepared for a public health emergency, should one arise.
How to Determine Your Medical Device Class
In order to classify your device, you must first locate its regulation number. You can find this number by searching either the FDA classification database, or by going to the device classification panel and finding the corresponding regulation for your device. Each device classification panel has a 7-digit number associated with it. Once you find your device and its corresponding number, you will then be equipped to find the device’s associated class, described in the FDA’s Code of Federal Regulations (CFR).
Here are two step-by-step examples on how to locate the classification of a simple medical device. In these examples we will use a standard, manual toothbrush.
Finding Your Device Classification through the Classification Database:
Enter the keyword “toothbrush” in the Device field of the Search Database, and click Search.
In this example, among the results is a listing for Toothbrush, Manual. There is an associated Regulation Number and Class. The class for this medical device is listed as Class I.
By clicking on Toothbrush, Manual, more product classification data can be seen, including product code, premarket review requirements, and exemptions.
Finding Your Device Classification through the Device Classification Panel:
Locate the correct medical specialty. In this example we will select Dental, medical specialty 76.
Click on the regulation citation to the right (872, in this example).
Find the appropriate Subpart and listing for your medical device (Subpart G–Miscellaneous Devices, CFR § 872.6855 target=”_blank” rel=”nofollow”, in this example).
There is even a classification for mobile medical applications. The FDA Mobile Medical Applications Guidance is located here.
The FDA’s website is full of valuable information for medical device manufacturers and distributors. Comprehensive information about how to study and market your device, premarket and postmarket requirements, classification, and quality and compliance guidance can all be found on the FDA Device Regulation and Guidance page.