For the betterment of healthcare enabling the end user get ultimate benefits of safety and efficacy, there is always a reserved space for invention in the field of medical devices. With the technological development, medical device manufacturers are always on their toes to come up with the best possible innovative products. As the invention takes place, the need to better market them also grows. The first and foremost thing that come in your way while doing so is to determine the class of your product as per the health authority regulations. What if you couldn’t find the type of class your device belong to? What if you couldn’t find information that matches with that of your invention? Here we explain…

Generally, medical devices in the United States are classified according to a predicate system. That is drawing comparisons to legally marketed devices and determining classification of I, II, or III based on the risk. To enable manufacturers, determine the classification of their device or to search for substantially equivalent (SE) of their devices, FDA provides a classification database. Once the SE is found, then the manufacturer can avail three letter product code and regulation number for registration purposes.

What if the SE is not found?

In case you are not able to find SE for your invention in the classification database, there is an option to request for information, i.e., submitting 513 (g) to FDA. Submitting 513(g) acts as a means to obtain the agency’s views about the classification and the regulatory requirements which may be applicable to your particular device.

A 513(g) submission should contain:

-        Characteristics of your device for which there is no information in classification database

-        Fundamental reasons to why you believe the device falls into specific class

Once the 513(g) received, FDA will evaluate the information and revert within 60 days, providing information on how you should classify your product with a product code and suitable regulation number.

In most of the cases, manufacturers can identify a SE in FDA device classification database. If not, there is need for 513(g) submission. While doing so, it is quite challenging to be vigilant on the data you need to submit and the formats you need to follow. Chose an expert Regulatory partner to sail through.


Related Posts by Category