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

by | Oct 5, 2021 | FDA User Experience Study, Genetic Testing, Regulatory Studies, User Comprehension

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. 
  1. 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
  1. 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).
  1. 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.
  1. 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.
  1. 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.
  1. 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. 

While the 510(k) process can be daunting, it is doable, and SoundRocket can help you on this journey. Well-designed user comprehension studies are our forte; if you’re looking to submit a 510(k), let’s chat!

Currently, the FDA only regulates true direct-to-consumer (DTC) genetic tests, which have no health care provider involved either before or after testing. Consumer-initiated, physician-mediated genetic tests are considered lab developed tests (LDTs), which currently do not require FDA oversight. 


Our Study Design

Our study was designed to simulate the experience of an everyday person who is considering doing a health-related genetic test. For this reason, we only reviewed website contents presented to a consumer before ordering a test. By limiting our data collection to pre-test content, instead of digging around or contacting the companies to fill in missing data points, gaps in public-facing information that consumers use to make ‘informed’ decisions were revealed.  

Also, while a genetic counselor supervised the project, a research assistant (RA) conducted most of the website investigations. The RA was familiar enough with genetics and genetic testing to understand and identify the information presented on the websites, but has not had the clinical exposure that might create bias from knowing how specific tests work “behind-the-scenes”. 


To Sum Up

We set out to understand the landscape of health-related consumer genomics testing from the public perspective. By limiting our research (by design) to public-facing pre-test website content, we could not complete our data collection as set out in the protocol. However, this uncovered an important observation: consumer genomics websites are highly variable in content, readability and ease of use. 

This begs the question, if we can’t find basic test information on a consumer genomics website, how does a consumer have enough information to make an informed choice about testing? 

Stay tuned for Part 2 in this series, where we will dig into our study findings and reveal our most interesting observations.  



As experts in FDA user comprehension studies for consumer genomics companies seeking 510(k) clearance, we are interested in how everyday people access and understand health content that is meant for them. If you need help optimizing your consumer-directed health communications, we’ve got the in-house expertise and experience to meet your needs. Let’s chat

About the Author

Jill Furnival

Jill Furnival is a certified genetic counselor and science writer based in Toronto, Canada. When she’s not helping people better understand genetics, you may find her walking her dog, or in downward dog! She joined SoundRocket in Fall 2020 to consult on user comprehension studies for the FDA authorization of direct-to-consumer genetic tests.