FDA floats new draft guidance, created by international group, on software as a medical device

Article Excerpt: The FDA has entered into the federal register a new draft guidance pertaining to “software as a medical device” (SaMD). The guidance is presented as representing the FDA’s current thinking on establishing clinical evaluation guidelines for SaMD, but is written by an international organization of device regulators, the International Medical Device Regulators Forum, of which FDA is a member.

Full Article: http://tinyurl.com/zzx3khf

Article Source: MobiHealthNews