The big news about 23andMe’s FDA approval came out last week when I was holed up at a conference.
— 23andMe (@23andMe) April 6, 2017
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.