Navigating the U.S. Food and Drug Administration’s (FDA) 510k submission process can be tedious. The FDA rejects 70% of first submissions, so accurately completing these forms can feel intimidating.

We’ve developed this article to help you understand the process.

Let’s begin with the basics.

What is a 510k?

Formally known as Pre-market Notification, a 510k is the collection of technical documents required by the FDA to sell a medium-risk medical device or In Vitro Diagnostic device (IVD) in the United States.

Medical Devices are defined by the Federal Food, Drug and Cosmetic Act (FD&C). If your product meets this legal definition, then you must determine its classification to determine its eligibility for 510k review.

The FD&C Act defines three device classes:

  • Class I: Devices that pose low risk to patients and users.
  • Class II: (the most important for us) Devices that could cause potential harm to patients or users if they malfunction, or are used improperly.
  • Class III: Devices that could severely injure or kill patients or users if they are used improperly or malfunction.

Most Class II medical devices and some Class I and Class III devices and IVDs require 510k submissions.

Timing

The FDA gives a timeframe of 90 calendar days to review your 510k documents. If you receive Refuse-to-Accept (RTA) or Additional Information (AI) letter, then the 90-day clock stops. Submitters have 180 calendar days to respond to the RTA or AI request.

About Predicate Devices

Gaining market approval in the U.S. is based on establishing “substantial equivalence” with a cleared device. You can do this by using the 510k database (Medical Device Databases) to identify an existing device with the same general purpose or function, which also has the same indications for use.

Now that we’ve covered the basics, let’s jump into the specifics.

510k Submission

The 510k submission starts from 20 individual sections that address each FDA requirement. All of the relevant protocols, test reports and other documentation are available as either attachments or exhibits. While there is no mandatory format for your 510k submission, each submission must also meet the FDA’s eCopy submission requirements in order to be accepted for review. The FDA does provide guidelines for formatting on their site here.

Next steps

You have successfully completed the requirements needed for your 510k submission, so now what?

Before you submit your 510(k) we recommend you review the Refuse to Accept checklist and make sure nothing is missing. Have a colleague review the submission as well – another set of eyes will help catch any errors.

When the FDA makes a decision, they will email a decision letter to the email address provided in your 510k cover letter. After this they add your “cleared” device to the 510k database.

Lastly, if you have any questions regarding this process or 510k in general, please reach out to our team. We will be happy to give you a free consultation to help you with your new device.

Summary

In the US, Medical Devices are defined by the Federal Food, Drug and Cosmetic Act (FD&C) and approved by FDA. Gaining market approval in the U.S. is based on establishing “substantial equivalence” with another cleared device. Strategies for accomplishing this revolve around identifying an existing device with the same general purpose or function, which also has the same indications for use. Generally speaking, it is recommended to choose a predicate that was recently cleared because it will have been cleared under the FDA’s more rigorous requirements. 510k submissions are necessary for most Class II medical devices. There could be also regulations for some Class I and Class III devices and IVDs. The FDA gives a timeframe of 90 calendar days to review your 510(k) documents.