A device that requires only general controls.
Class I Device
Share / Follow
RUO + NGS = FDA FTW MolDx and the prisoner's dilemma
How Soon is Immediately? Does 23andMe have 15 days to comply?
Day Two: FDA vs 23andMe Some additional thoughts on FDA for our friends on Twitter
FDA Drops the Hammer on 23andMe Possibly the most devastating warning letter ever