23andMe's app.
In a public letter dated November 22, the Food and Drug Administration has instructed personal genome startup 23andMe to immediately stop selling its testing service until the offering receives de novo 510(k) clearance. Regulatory Focus first spotted the letter.
"[M]onths after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not...
Strategies for mHealth Companies Wishing to Avoid FDA Regulation
By Bradley Merrill Thompson
(I would like to thank Leah Kendall of EpsteinBeckerGreen and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be attributed to anyone else.)
Most people know the difference between tax avoidance and tax evasion. Tax...
