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...
From the LaunchPad
Welcome to The Launchpad, SoundRocket’s blog, where we share our insights and musings on the science of doing science (well), #soundscience.
The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 1)
So, you’ve developed a genetic test that you’d like to sell directly to the public in the U.S.—from a regulatory perspective, what do you need to know? To start, some genetic tests require U.S. Food & Drug Administration (FDA) review before being marketed...
The Trouble with UNinformed Consent in Direct-to-Consumer Genetic Testing
Today we are bombarded with online terms of service, contracts, and privacy policies. Whether we are signing up for Spotify or online fitness classes, clauses of click-through legalese lead to the inevitable checkbox – I have read the details and I agree. ...but it...
Using a Label Comprehension Study for Nonprescription Drug Products
Over-the-counter drugs and direct-to-consumer genetic tests need to stand alone: here’s how the FDA ensures label comprehension. At SoundRocket, we have spent some time talking about the #SoundScience that is associated with FDA user comprehension studies. These...