Is my Software a Medical Device? - Medical Devices Group

Design Assurance Engineer at Mallinckrodt Pharmaceuticals

February 2017

< 1 min reading time

If it looks like a duck, swims like a duck, and quacks like a duck, then it’s probably a duck…

Medical devices can be purely hardware based (eg stethoscopes), be composed of hardware and software (eg patient monitor) or purely software (eg mobile medical apps).

In both the US and the EU, standalone software, such as a mobile app, can be a medical device in its own right if it has a medical purpose. This software may operate on a general purpose platform such as a smartphone and typically falls under the jurisdiction of a medical device regulatory authority. Such software is generally called Software as a Medical Device or SaMD.

1. What is Software as a Medical Device (SaMD)?

Software as a medical device (SaMD) is software that’s intended to be used for a medical purpose and that performs this function without being part of a hardware medical device, i.e. it runs on general purpose (non-medical purpose) computing platforms. For example, mobile apps that meet this definition are considered SaMD.

2. How do you determine if your software is a medical device?

This can vary depending on the country of sale, but in most jurisdictions (US, EU), the software is a medical device if the manufacturer (the person who legally markets the product) intends it to be used for a medically related purpose.

In other words, your software is a medical device when its intended use falls under the definition of a medical device.

The intended use is reflected in the specifications, instructions and information provided by the device (software) manufacturer.

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Posted by Matteo Gubellini

Asked on February 17, 2017 12:00 am

251 views

	Private answer Julie Omohundro Nice summary. I've found that the most common tripping point is a too-narrow understanding of what regulators consider a "medical purpose," especially among developers who have no prior experience with FDA-regulated products. A related problem is the failure to document their rationale for concluding that their software is not a medical device, if that is what they have concluded. Marked as spam Report spam
	Private answer The controlling s/w is much more important than the device or machine to be controlled. Hand commits a fault but orders are given or issued by the brain. Marked as spam Report spam
	Private answer Nice! It would be great to quote a few hot selling products. Marked as spam Report spam
	Private answer Thanks for posting, Matteo. Informative and nice opener, just quacking!! Marked as spam Report spam
	Private answer am really interesting to see this posting messages.. in future am advice to manufacturing company or organisation . Marked as spam Report spam
	Private answer It makes sense. But I've never come across an app that is, for instance, FDA approved. Are there such medical apps? and does the approval process differ from conventional hardware approvals? Marked as spam Report spam
	Private answer Thank you. Marked as spam Report spam
	Private answer Julie Omohundro Richard, in what sense is the user a patient? Marked as spam Report spam
	Private answer I'd consider a medical instruction something that would probably be given by a medical doctor instead of the software. Everything that you could conclude from common sense or, say, wikipedia etc., would not fall under medical instruction. But finally it would help if the publisher of the software in question would also publish its 'intended use' and some rationale, why it is NOT considered to be a medical device. Marked as spam Report spam
	Private answer Basics are covered, but have a look at the notes here... NOTES: o SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device. o SaMD is capable of running on general purpose (non-medical purpose) computing platforms o “without being part of” means software not necessary for a hardware medical device to achieve its intended medical purpose; o Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device. o SaMD may be used in combination (e.g., as a module) with other products including medical devices; o SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software o Mobile apps that meet the definition above are considered SaMD. Full text: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm524904.pdf Marked as spam Report spam
	Private answer Matteo Gubellini The FDA has published a really good guidance on MMAs (Mobile Medical Apps). It lists cases and examples of what they consider medical devices, what not, and what they do and do not intend to enforce. https://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/ucm255978.htm Marked as spam Report spam
	Private answer I'd suggest everyone who is unsure start with the FDA Guidance Matteo links to above. It will help clear up a lot of your uncertainties and perhaps even provide answers. Marked as spam Report spam
	Private answer Julie Omohundro Amin, unfortunately it isn't possible to search FDA's premarket databases for SaMDs or MMAs, but FDA has listed some of the MMAs it has cleared or approved since 1997 here: https://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/ucm368784.htm The clearance/approval process is the same for these medical devices as for any other medical devices. I would guess the vast majority have been 510(k) devices that trace back to hardware devices that were cleared for the same intended use. As I recall, at least one software device has also come to the US market by the new direct De novo process. I think this will be the path to watch for the really interesting innovations in the future, as this would be the path for software devices that can be used in ways that a hardware device could not, rather than just to replace hardware devices that did essentially the same thing. That's when this space will start to get really exciting. Marked as spam Report spam
	Private answer Really interesting article Matteo - it's a question a number of my clients think about from a risk perspective so this is a useful share. Thank you. Marked as spam Report spam
	Private answer Sure, sir. For example the solution BIOSERVPRO offers is the best one. Www.bioservpro.com Marked as spam Report spam

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