Label comprehension studies test how well a typical consumer can understand the labeling for an over-the-counter (i.e., non-prescription) drug or medical device. The labeling may include the product box or the instructions for use found inside the package. The idea is...
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.
FDA User Comprehension Studies
What is an FDA user comprehension study? The US Food & Drug Administration (FDA) is responsible for identifying and mitigating consumer risks associated with the products it’s charged to regulate. This includes both prescription products and those sold...
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...
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...
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...
How SoundRocket Helped Ancestry.com Achieve FDA Approval (K192947) with Online User Comprehension Studies
When the pandemic began forcing companies to close their physical doors in March 2020, SoundRocket’s Founder and Chief Vision Officer Scott D. Crawford packed up a few belongings and told employees, “Let’s see how this goes. I’m sure we’ll return in a couple of...
DNA Matchmaking: Move Over, Cupid.
Based on a 2020 survey by dating app Plenty of Fish, 90% of US-based daters feel chemistry, not attractiveness, is the key to a lasting successful relationship. Genetic matchmaking sites that offer DNA testing to predict biological compatibility (i.e.: chemistry) couldn’t agree more.
With Valentine’s Day around the corner, we are taking a peek at these direct-to-consumer (DTC) genetic tests and the science behind DNA–based dating . . .
Research Wonder: DNA with a bow on it, a gift that may (unexpectedly) ‘keep on giving’
If you’re looking for a last minute gift for friends or family this holiday season, you may be considering direct-to-consumer (DTC) genetic testing kits. These saliva-based at-home DNA tests (offered by companies like 23andMe and Ancestry.com) are available for quick...
Decoding FDA DTC Policy in the Genetic Testing Space: The Complete Series
Prefer to read all five posts about the recent FDA Pharmacogenetics Test Report activity at once? We have compiled the full week here into this one post…