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...
FDA
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 . . .
Ancestry closes DNA Health Business only months after obtaining FDA DTC Approval (K192944) with SoundRocket help
More news in the consumer genomics space came this month when direct-to-consumer genetic testing company Ancestry announced they are discontinuing their AncestryHealth business. This move comes just months after receiving FDA approval for a direct-to-consumer...
Helix enters DTC game with broad whole exome sequencing platform
Helix made headlines when they announced authorization from the U.S. Food & Drug Administration (FDA) for a whole exome sequencing platform, called the Helix Laboratory Platform. In the same breath, they also announced they obtained 510(k) clearance for their new...