FDA Breakthrough Device can be overlapped with a designated device?

Brian K

Starting to get Involved
Hi,

I'm working and trying to get FDA Breakthrough device for AI software medical device.

There is no predicate device of my device, so I was working to get FDA Breakthrough device before we submit De novo application.

But suddenly, my competitor got FDA Breakthrough device recently for their device which is similar of ours(mostly same intended use and operation of principle).

Can we get second FDA Breakthrough device in this case?

Highly appreciate in advance !
 

Brian K

Starting to get Involved
I guess criteria you meant is about Designation criteria from FDA guidance (breakthrough device progam), right?

It is not clear about this criteria but
1) the device provide for more effective treatment or diagnosis, and

2) represent breakthrough technologies(A.I tec.)

Could you kindly explain me about criteria if I'm wrong?
 

mihzago

Trusted Information Resource
Just because the competitor obtained the designation does not mean their product is available or that it will even be cleared/approved.
This program does not accelerate or ensure positive outcome.
In my opinion, most companies that enter the Breakthrough designation do a disservice to themselves. They believe more interactions with the FDA are better, where most of the time that's not the case, at least in my experience. The more interactions with the FDA you have, the more opportunity you give them to ask or recommend things that during a normal review process you may have better chance on pushing back on.
 

Brian K

Starting to get Involved
Thanks for your advice

You think normal review(de novo) will be appropriate to get more benefits for us.

Then what breakthrough program provides benefit to manufacture? Priority review?
 

Watchcat

Trusted Information Resource
Could you kindly explain me about criteria if I'm wrong?

I don't think I can explain FDA's criteria any better than FDA has explained it in its guidance.

As for whether or not your device meets the criteria, I'm in no position to say, since I'm not familiar with your device, other devices in the same space, applicable standard of care, etc. The best I can tell you is that you are correct in thinking that your device will need to meet the first criteria in the guidance and then one of the remaining four. Then you have to figure out what data and information to provide FDA to show that it meets those criteria.
 

Watchcat

Trusted Information Resource
In my opinion, most companies that enter the Breakthrough designation do a disservice to themselves.

I would guess that some number of startups are at least trying to do themselves the "service" of attracting funding, because they think "breakthrough" sounds "better" to investors. Whether or not it does, I can't say.
 
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