You are a senior compliance officer at a medical device company. The Director of Compliance has requested you review the following two articles:
(1) Innovation, Risk and Patient Empowerment/FDA Mandated Withdrawal of 23andMe and
(2) FDA versus Personal Genetic Testing
and prepare a short post for the internal employee blog summarizing the FDA’s activities concerning 23andMe.
What role does the FDA play? Why did it take this action? How would this apply to products or services you might develop?