US FDA Medical Device Classification
Unlike the rules-based classification schemes used in Europe, Brazil and other markets, medical devices in the US are classified using a predicate-based system. The US Food and Drug Administration (FDA) uses this system to classify medical devices as Class I, II or III based on increasing risk to the patient or user.
Determining the US FDA classification your medical device
In most cases, you can determine the correct classification of your medical device by referencing the FDA’s classification database and reading the descriptions of devices that are “Substantially Equivalent” to yours. Once you have a match, you will be able to determine the classification, three letter Product Code and the specific regulation number that will be used during the registration process. This may seem easy, but identifying the closest FDA predicate device to yours among thousands of codes is often harder than it seems.
Submitting a FDA 513(g) if no clear predicate can be established
For devices that are innovative, it can sometime difficult to find an exact predicate device using the FDA classification database. In this case, you can submit a 513(g) “Request for Information” to the FDA. The 513(g) submission should outline the characteristics of your device and include rationale on why you believe it falls into a specific class. The FDA will evaluate your information within 60 days and issue a ruling on how your device should be classified along with a suitable regulation number and product code. Read the FDA 513(g) guidance document.
FDA De Novo Submissions for new devices
Entirely new devices are automatically considered to be Class III in the US. However, many new products are not high risk. This is why the FDA has the "de novo" process. You may consider filing a “de novo” submission if the FDA determines, through means such as a 513(g) or Pre-Submission, that your device is a “novel” with no existing classification or predicate device on the market. Within 120 days after your de novo submission, the FDA will determine if your device is Class I or II and may issue an entirely new product code and regulation number. If rejected, your device will remain Class III. Read this De Novo guidance document from the FDA.
Allow Emergo to help you classify your medical device in the US
Emergo specializes in medical device regulatory consulting and can help you determine the proper classification for your device in the United States. Here’s how we can help:
- We have many years of experience navigating the complex USFDA classification database to properly classify devices. We know which mistakes are commonly made and how to avoid them.
- If the classification of your device cannot be determined using the FDA classification database, we can advise you on whether to submit a 513(g) or De Novo submission to the FDA.
- If a de novo submission is necessary for reclassification, our team of consultants will determine the correct de novo pathway, submit it to the FDA and provide support in handling FDA feedback after submission.
Proper USFDA classification of your device is extremely important to avoiding regulatory delays and expenses. Let us help you get it right the first time and get your product cleared for sale as quickly as possible.