Since past few months, mobile health application developers have been looking for answer to their two questions: 1) When is FDA clearance required? 2) How to achieve FDA clearance?
Bradley Merrill Thompson has answered the above two questions in his article at mobilehealthnews . The article in 3rd in series where in first article, he outlined what factors FDA considers while deciding which products need to be regulated. In second article, he outlined basic steps for getting medical device cleared by FDA.
The article is must read for any mobile health application developers considering selling their applications in US.
Bookmark to:
