The Food and Drug Administration also known as (FDA), created about 1700 classification for different types of generic devices. They also grouped them into 16 medical specialties known as “Panels”.
These generic types of devices are assigned under three regulatory classes established by the FDA. The three regulatory classes are defined as Class I, Class II, and Class III. The 16 medical specialties are assigned to the three regulatory classes based on the level of control essential to confirm the safety and effectiveness of the device.
What does these three classes mean to a new device seeking an approval to market in the US?
The class your device falls under, will be the decision factor, among many other factors, the type of pre-marketing submission / application the FDA will require to clear your device for marketing.
If your device is classified as a class I or Class II, and it doesn’t fall under exempt, you will need a 510 K for marketing. Devices classified as exempt can still have limitations of exemptions.
FDA requires premarket approval for (PMA) for Class III devices, unless the device is a Pre-amendments Device. A device in the market before the medical device amendment (MDA) was passed in 1976? or device substantially equivalent to such device? PMA isn’t required in this case.
In this case, if a PMA has not been called for, a 510K will be a route to pursue.
Device classification really depends on the intended use of the device, and upon the indications for use.
Device classification is also based on risk. The risk the device poses to patients is a big factor, that determine which class the FDA categorize your device.
Class I devices is classified as low risk, Class II moderate risk and Class III has the highest risk classification.
To determine the classification of your device, and any associated exemptions that may exist, you will need the regulation number. The classification regulation for your device can be found either by using the classification database or you can also search for a part of the device name, or use the device panel.
Many medical devices already classified can be found by searching for its description in the CFR, Parts 862-892 as listed at the FDA’s website.
FDA’s Panel Classification is useful if your device is listed, but what if your device is a Novel device. A Novel device is a new device that is new to the market not yet classified. Hence, you cannot obtain regulatory information using FDA’s existing database.
You will need a 513g submission for a formal submission, or an informal request to the FDA to help start the process of classifying your novel device.
At TEDMED Engineering and Projects, we are specialized with making this process short and painless. Reach us to assist you with all process involved in getting your product out to the market.
Call 678-689-4046
(877)-255-7660
Written by
Elizabeth Betty Bonsu
Founder & President, TedMed Engineering & Projects
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