Software bug fixes after shipping a product

anbknaga

Starting to get Involved
#1
We have developed a mobile application that shows the data in real time from a medical device when paired. Since this app, just shows the flow rate details in real time, we are calling this as a "add-on service".

In future, if the organisation decides to update the UI/UX or make bug fixes, should we inform our customers or regulatory authority by a separate portal? or is it just enough to send a pop-up requiring them to update the app and that will be enough?
 
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yodon

Staff member
Super Moderator
#2
Probably not enough information to give a complete answer but let me toss out a few things. I don't know for example, if your device (software) requires FDA market clearance.

First, IEC 62304 is the standard for medical device software lifecycle. There is a section on maintenance and postmarket support.

Second, FDA has a guidance on when to submit a new 510(k) when changes are made. I don't know if you are required to submit a 510(k) but it shows their general thinking on the matter. (And do note that you should consider the accumulation of changes, not just each individual change independently.)

If this is considered 'general wellness' software then there's an FDA guidance on that which may give you some insight.

How you deal with your end users for an update is not specifically mandated but actions should be driven by risk. Again, not knowing your device, it's hard to say but if you had a bug that could lead to patient harm (possibly indirectly) then your actions would be elevated as opposed to a change for, say, just aesthetics.
 

mihzago

Trusted Information Resource
#3
as yodon said, not enough info to provide qualified response, it really depends on the type of change (e.g. risk involved) and classification of your device. If you're fixing defect to address safety issue (e.g. did you provide incorrect data?) or violation of the act (e.g. your device did not perform as advertised), then you have to consider 21 CFR 806 and possibly 803.
 

dgrainger

Trusted Information Resource
#4
Looks like it qualifies as an accessory to the device. Is this add-on function mentioned in the device's IFU or any promotional materials?
 
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