Article Excerpt: As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing claims) crosses over into regulated medical device territory. As always the agency is seeking comment from the industry and the public on their new draft guidance for the next 90 days.
Full Article: http://tinyurl.com/pwhpcad
Article Source: mobihealthnews