software as a medical device

By Jonah Comstock April 26, 2018
This morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD). Though still preliminary (the agency is asking for comments by the end of May), the publication comes with some long-awaited details about how the program might work. The document lays out five "excellence principles" on which companies applying for...
By Dave Muoio March 13, 2018
A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes suggestions on how the FDA’s pre-certification pilot program and other initiatives could better serve this fast-moving industry. “The exponential advancement of digital health technologies presents a...
By Heather Mack November 28, 2016
As the world’s medical device regulators work to harmonize how best to regulate software as a medical device (SaMD), MobiHealthNews has learned via a Freedom of Information Act request that the FDA invited Apple to join an international task force focused on shaping this future regulatory framework. Apple executives quietly joined a working group within the International Medical Device...
By Jonah Comstock October 17, 2016
The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD).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. The...