The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 2)

So, you’ve developed a genetic test that you’d like to sell directly to the public in the U.S., and you’ve read Part 1 of this two-part series—then you are ready to get some insider tips from a genetic test FDA expert on how to navigate the 510(k) process for your direct-to-consumer genetic test (DTCGT).

Quick tips on 510(k) submissions for DTCGTs:

1. Call in the experts. There are many nuances to a 510(k) submission, and we’ve learned experience matters. Seek the help of a regulatory affairs consultant with strategic knowledge (and 510(k) success!) to guide you through this process. Don’t know who to turn to?—We can help identify the right expert for your product. 

2. Establish your predicate. The predicate device needs to be similar in intended use (i.e.: labeling) and in technology to your genetic test, but it does not have to be identical. 

3. Review the controls and special controls described in the regulation for your type of device, (e.g.: for a GHR test, read 21 CFR 866.5950) to create a checklist of the specific regulatory requirements for your genetic test. For example, one special control in the GHR regulation is the required use of an FDA-cleared sample collection device, like the Oragene Dx saliva kit (K141410).

4. Get help from the pros with your FDA user comprehension study. Turn to survey experts (like us) who are familiar with user or label comprehension studies for regulatory purposes, as we know what the FDA is looking for in study design, sampling, data management, comprehension level, and reporting.

5. Use the regulatory process to improve your product, don’t just check regulatory boxes. User comprehension studies will give you tremendous insights into how to better your DTCGT product. Consider (and embrace) this process as an extension of product development.

6. Consider a pre-submission. If you have any questions about your 510(k) approach or how well you compare to the predicate, consider applying for a pre-submission meeting with the FDA to confirm that you are on the right track. A regulatory medical device expert can give invaluable tips on how to effectively communicate with the FDA.

7. If at first you don’t succeed, try, try and try again. If the FDA declines your submission (i.e.: you get a Not Substantially Equivalent or NSE determination), don’t lose hope; find out why, make the necessary changes, collect more data, call in the experts (if you haven’t already), and try again. If you have a novel device, you may need to consider the De Novo route. 

What success looks like

When your application is successful, the  FDA will issue a decision letter to you indicating that your device has been cleared for the specific indication for use and they will assign a unique 510(k) number. Then, you can complete your registration, list your device with the FDA and launch your DTCGT product.