FDA Busy With Software

Since connectivity runs on software, and some medically related software is a medical device, and medical devices are regulated by the FDA, those involved in connectology must pay at least some attention to what the FDA is saying about the subject of medical software that is not an inherent part of some other medical device.  In this regard the FDA speaks in multiple ways, ranging from regulations, to final guidance documents (fGD), to draft guidance documents (dDG), to more casual public comments. Recently (since October 1st) the FDA has been busy in the software space by releasing several new fGDs and dGDs that specifically address software. I will outline these here. Overall the FDA identifies over 20 guidances with "digital health content".  In addition, other general guidance might also be relevant to medical software even if software is not their named focus. There have been two final guidances related to software since October 1st, along with 16 other new fGDs. The first of particular interest to us is Deciding When to Submit a 510(k) for a Software Change to an Existing Device which I have already addressed here. The second is Software as a Medical Device (SAMD):Clinical Evaluation. We discussed a draft of this document back in December, 2016. SAMD is software that on its own is a medical device, as opposed to software that is in or part of another medical device. Like medical devices generally, SAMD  devices have to be shown to be safe and effective (or maybe ...
Source: Medical Connectivity Consulting - Category: Information Technology Authors: Tags: Standards & Regulatory Source Type: blogs