Can we register non-device clinical decision support software under draft guidance?

#1
Hello everyone,

I am hoping someone can help me. I have read the draft guidance for clinical device support (CDS) software and am wondering if non-device CDS software can be marketed even without the guidance being finalised?

And if so, does anyone know the process of doing that? Do we just have notify the FDA of the product?

Thank you
 
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yodon

Staff member
Super Moderator
#2
Guidance documents are not binding and certainly not a draft guidance! It does reflect "current thinking" so following it is a good idea. The (draft) guidance lays out a decision table for whether the CDS would be considered a device or not. It sounds like you've gone through that and concluded it's NOT a medical device? If it's not a medical device then the FDA has no jurisdiction so you could market without any notification.
 
#3
Oh brilliant. I wasn’t sure if it would be allowed to be marketed like that at the moment. That’s great news. Thank you very much
 

Watchcat

Trusted Information Resource
#4
I concur with yodon on guidances. They reflect FDA"s "current thinking" on specific regulations, but it is the regulations that determine what you can and cannot legally market, not the guidances. This particular guidance provides CDRH's current thinking on how the definition of a medical device in the regulations applies to CDS software.

So here's the important thing. If you decide it's Not a Device, then be sure you have a well-documented justification for this determination on file. Otherwise, if you made the wrong call...it's not so much FDA you have to worry about, but any competitors who have "substantially equivalent" products that they have determined are, in fact, medical devices, and have therefore invested resources to comply with FDA regulations applicable to medical devices.

If your software starts to make significant inroads into market share, these competitors are likely to point you out to FDA. And then it will be FDA that you have to worry about. :( Of course, if none of your competitors have their software listed with FDA, that means they have determined that their software isn't a medical device, either.

PS Is it just me, or is it weird that Table 3 indicates that FDA will focus its regulatory oversight on software that the table identifies as "Not a device"?

https://www.fda.gov/media/109618/download
 
Last edited:
#5
Thank you. That’s great. That really clears it up for me! Also regarding table 3 I always took that to be even if it’s not a device if the user is the patient or the info can’t be independently reviewed then the FDA need oversight
 
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