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Registering a new device with the FDA can be tricky. The first step is to choose what pathway to follow for the submission. One of the most common submission pathway ways used is the 510K pathway. Even after choosing the 510K pathway, a company will still have to choose which type of 510K to choose from – traditional, abbreviated, or special. While each type has the same basic structure there are significant differences between them, to learn more about those differences check out this blog. Regardless of what type of 510K is being submitted there are a few basic tips that can be applied.

First and foremost, be prepared. Understanding everything the 510K submission will require will help a company submit the application in a smoother manner. 510Ks often require the same specific documentation no matter the device. Where the biggest difference can come in is the testing documentation required. Some devices may require a large amount of testing while others may only require a handful of tests. Testing that is often required is sterilization testing and biocompatibility testing. The FDA has drafted guidance documents that apply to specific devices or types of devices that list the testing requirements for the 510K. Knowing what testing is needed and having the documentation ready will enable a company to complete their submission all the quicker.  

The next tip is to know the predicate device. A 510K requires that there be a predicate device to the device the submission is being made for. A predicate device is one that has already been approved by the FDA and equivalence is being drawn to.[1] Essentially the device that the new 510K is being submitted will be compared to this predicate device. The company submitting the new 510K gets to choose which device to list as the predicate device and it can be any device already approved by the FDA, even ones from other companies. Examining the 510K of the predicate device and seeing what that submission entailed will give insight into what is needed for the 510K of the new device.

Finally, have patience. Getting approved by the FDA takes and while there may be the desire to rush to submit the application to speed up the process even just a little bit, it is better to take the time to ensure that the submission is done right. The process will take time no matter what so it is better to get it right the first time. EMMA International can help prepare and submit a 510K. The team at EMMA International can also provide assistance with registering products in other countries and markets. EMMA International provides Full Circle Consulting serivces, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (March 2020) Premarket Notification 510(K), Retrieved 12/11/2021 from https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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