FDA and OTC (Over the Counter) Software Use Classification

S

SmallD

#1
We have been asked to "classify" for FDA purposes a piece of software written for an OTC software package (not ours).

Please try to follow my thoughts and let me know if there are any flaws:

1) OTC SW is defined in FDA MDDS as "Standard IT software that is not specifically sold by the manufacturer as a MDDS, which may have MDDS functionality such as reading serial numbers, barcodes, UDI or other data from a medical device, but is not used in providing patient care."

2) We add to the OTC SW our plug-in that provides a measuring function for displayed medical data (ECG), according to FDA this addition of modifying data/display of data disallows MDDS classification (FDA - An MDDS does not modify the data or modify the display of the data).

3) So by the way of adding the plug-in, have we turned the OTC SW into a medical device?

My conclusion: OTC SW (for reading ECG PDFs) + plug-in (for performing and saving measurements on ECG PDF) = modifcation of data/display of data and is used in providing patient care = medical device!
 
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I

isoalchemist

#3
I agree with your conclusion, if you are performing any modification to the data or adding any capability that will that will support/enhance a diagnosis you cross over into the FDA realm.
 

cmeby

Involved In Discussions
#6
uhhhh...because they give us insight into the way the governing body is leaning towards and views certain specific subjects...so we can be prepared when/if the guidance becomes rule in the USA where we might have our products registered?
To ignore them entirely when they apply to a product line you are developing does not make sense to me.
Again - trying to be helpful :)
 

sagai

Quite Involved in Discussions
#7
;)

The Guidance is not a rule.
The draft Guidance neither.
When you reference it, for me it's a kind of manifestation that you voluntarily bind yourself to its full content. Do you really wanna get additional weights to your shoulders on the top of the CFRs? :rolleyes:

:bigwave:
 
Last edited:

cmeby

Involved In Discussions
#8
did not say it was a rule
Referencing something published by a regulatory body is not binding yourself to its content - it is called being informed.
This conversation with you is over - you remind me of a troll on the internet forums...deliberately picking wars with people.
My suggestion to consult the draft guidance was helpful in my opinion for someone who is trying to classify their product.
I do not see your follow-up post being helpful at all. (not the first time either)
 

sagai

Quite Involved in Discussions
#9
It is unfortunately very typical that people look into the guidances as a rule whereas those are not.
Your referenced post was also partially about it, please read your own post.
That was the whole point, to caveat, Guidance is not mandatory and not a rule.
As long as your last post intended to offend me in some way, I ignore that part.
Cheers!
 
I

isoalchemist

#10
Guidance is not mandatory and not a rule.
!
But guidance and draft guidance does reflect the current thinking of the Agency and if you are attempting to understand where your product/process falls in the regulatory quagmire they are a very good place to start.

You are not required to follow them, but if your conclusion differs significantly from the guidance you better be prepared to defend why you made your decisions and document it.:2cents:
 
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