23andMe Gets FDA Authorization for Consumer Genetic Health Risk Reports

The big news about 23andMe’s FDA approval came out last week when I was holed up at a conference.

That’s right. 23andMe can now directly offer consumers a genetic health risk report that’s FDA approved. This is a big step for 23andMe when you consider that they’d previously gotten their hand slapped by the FDA.

23andMe got what’s called a de novo authorization from the FDA. This is something we’re likely to see more of and something that I’m sure many people aren’t familiar with. Here’s a description of what a de novo authorization is from the 23andMe announcement:

What does it mean to be granted a de novo authorization?
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option, which provides an alternate pathway to classify novel devices of low to moderate risk. The de novo process is used by the FDA to grant marketing authorization for devices that are new and unlike any other on the market. In addition de novo marketing authorization means that 23andMe met the FDA’s premarket requirements to demonstrate the following: accuracy, validity and user comprehension.

I’m glad that the FDA has created this new form of authorization for companies like 23andMe. This story also stands in stark contrast to other FDA related stories like Theranos. I’m sure that 23andMe would hate the comparison. However, there are some similarities. They both got slapped by the FDA. However, their response to the FDA’s notices was completely different. That’s why 23andMe seems to still be thriving and now have FDA approval. Theranos is floundering with reports that their founder now owes the company $25 million.

Needless to say, if you’re a healthcare startup, make sure you know the FDA regulations that apply to your startup.

About the author

John Lynn

John Lynn

John Lynn is the Founder of HealthcareScene.com, a network of leading Healthcare IT resources. The flagship blog, Healthcare IT Today, contains over 13,000 articles with over half of the articles written by John. These EMR and Healthcare IT related articles have been viewed over 20 million times.

John manages Healthcare IT Central, the leading career Health IT job board. He also organizes the first of its kind conference and community focused on healthcare marketing, Healthcare and IT Marketing Conference, and a healthcare IT conference, EXPO.health, focused on practical healthcare IT innovation. John is an advisor to multiple healthcare IT companies. John is highly involved in social media, and in addition to his blogs can be found on Twitter: @techguy.