Non-Device MDDS Clarifications (FDA)

K

KhPat

Starting to get Involved
#1
#1
Hello,

I am hoping someone could provide some clarifications regarding FDA's non-device MDDS classification. We are a manufacturer based in Canada and we would like to have a software approved which uses three (3) FDA approved sensors (one that we manufacture and two of other manufacturer). All sensors are to be connected to one single user interface which will take the data from these sensors and simply display it on the UI (no calculations are happening).

Would this be considered a software functions under FDA's regulatory oversight or a non-device MDDS, if anyone has seen a similar situation before. How are they marketed in the USA? If any specific guidance documents which I can refer to please kindly share it would be appreciated.

Thank you!
 
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mihzago

mihzago

Trusted Information Resource
#3
#3
It depends what you intend that information to be used for.
If you transfer that data, for example just for record keeping, then it's not regulated, but if you display the data real-time or near-real-time for monitoring, then probably regulated.
Keep in mind that it's not only the functionality but also what you say to the user of the data they can do with the data.
 
K

KhPat

Starting to get Involved
#5
#5
ECHO said:
I would say it depends on the "3 FDA approved sensors".
Here are some readings that might help.


So the three sensors can be connected to the display monitor (which has the software) to display ECG, oxygen saturation and tissue oxygen saturation. Basically all three sensors are already approved but there will be a software developed to display this information on a single user interface.
Click to expand...
 
mihzago

mihzago

Trusted Information Resource
#6
#6
what is the purpose of displaying this information and who is it displayed to?
are there other cleared software devices that perform same or similar function?
 
K

KhPat

Starting to get Involved
#7
#7
mihzago said:
what is the purpose of displaying this information and who is it displayed to?
are there other cleared software devices that perform same or similar function?
Click to expand...
This software will allow healthcare providers to continuously display these parameters in all settings in which critical care is provided. Each of the sensors have been approved by FDA as their own systems which includes sensors + software. However, I am not 100% sure if there is any other cleared software device that performs same or similar functions.
 
mihzago

mihzago

Trusted Information Resource
#8
#8
I would say this squarely falls into the regulated area.
I was asking if you know of any similar or competitor devices with clearances/approvals because that's one way to quickly determine if your may be regulated.
I think you'll find a lot of similar devices in the cardiovascular devices panel, Cardiovascular Diagnostic Devices and Cardiovascular Monitoring Devices.
 
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