Posts Tagged ‘Food and Drug Administration’
Is Digital Health Software Subject to FDA Regulation?
If you work in the software industry, you may be surprised to discover that digital health software products may be subject to regulation by the Food and Drug Administration (“FDA”). Some software is considered a software as a medical device (“SaMD”) product or software in a medical device (“SiMD”) product. So, how do you know…Read More
What is the Concept of “Digital Health”?
What is the concept of “Digital Health”? If you work in the field and are still unsure of how exactly to define the term, then you are in good company: while there seems to be some consensus regarding what is included in the concept of “Digital Health,” there is still some confusion on the scope…Read More