Mitchell Parrish, JD, RAC, CIP, VP of Legal and Regulatory Affairs
Considering the breadth of the FDA’s new draft and final guidance, there is plenty for multiple audiences to consider. One audience includes developers of software or applications intended to promote a healthy lifestyle. The new applicable guidance signals the FDA’s view that these products are the electronic equivalent of dietary supplements. Just as dietary supplements can avoid being classified as a drug thereby reducing regulatory burden, software or applications can do the same. This is so long as their marketing claims are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition.