www.fdanews.com/articles/155870-expert-fda-letter-on-mobile-app-may-bring-welcome-clarity-to-field
Expert: FDA Letter on Mobile App May Bring Welcome Clarity to Field
May 28, 2013
A rare enforcement action against a mobile app developer for failing to get 510(k) clearance may have a positive effect by setting boundaries for the rest of the field, one mHealth expert says.
Devices & Diagnostics Letter
Devices & Diagnostics Letter