Sources: 1. https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-frequently-asked-questions-faqs 2. IMDRF SaMD WG N10/Software as a Medical Device 3. Canary2

** Does FDA regulate SaMD?**

SaMD is defined by IMDRF. For software to be regulated by FDA as a device, the software must meet the definition discussed in [[09272407361 RN FDA Webinar Digital Health]]

** Medical purpose vs non-medical-purpose software**

Software used to make or maintain a device (eg testing, source code management, servicing) is not considered to be software with a medical purpose (by IMDRF).

** Definition of SaMD**

Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

NOTES:
- 'without being part of' means software not necessary for a hardware medical device to achieve its intended medical purpose
- Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device
- SaMD is a medical device.

** Read on functions typical in active implantable ecosystem**

• Software that turns on / off therapy cannot be SaMD (drives a hardware medical device).
• Software that programs the therapy parameters cannot be SaMD (because that software is necessary for the hardware implant to meet its intended medical purpose)
• Software that receives, stores and transmits patient / device information (eg some server collecting device logs / registration information)… well, depends on whether we are a “Medical Device” per IMDRF definition. I don’t think so. I think that’s falling on the non-medical-purpose side of things.
• Software that pushes patches down to the implant (aka servicing, which was called out as ‘not considered software with a medical purpose’ in the note in Introduction section of SaMD WG/N10)

Hm, where does that put us for Mainstay? RC/Prog. as SiMD? (software in medical device)? Or software as accessory to medical device…