This post was published by Jon Speer, the Founder and VP QA/RA at Greenlight Guru.
Medical devices are a big business covering a wide range of modalities and applications. To ensure the safety of these devices, the Food and Drug Administration (FDA) publishes guidelines and regulations that assess the safety and efficacy of new devices that go to market.
In an August 2016 publication, the FDA released a draft guidance document which details its current thinking on one of the fastest growing trends in medical devices: Software as a Medical Device, or SaMD.
This article highlights the most crucial aspects of this document from the standpoint of medical device manufacturers. The new guidance on SaMD clarifies how existing regulations can be applied to software medical devices, including a newly proposed categorization framework. This draft guidance should be seen as an update for earlier guidance documents that accounts for new trends and concerns in the SaMD industry.