Predetermined Change Control Plan

QuinnM

Involved In Discussions
Hi,
The FDA identifies about 700 AI/ML medical devices in the US market. I'm interested to know of the 700, how many have a predetermined change control plan ("PCCP")? If public information what companies have successfully submitted the PCCP?
Quinn
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Few. The real power in AI is in "self-learning" and updating. Most colleagues I've spoken to have seen FDA nitpick their PCCP down so far they gave up and will just submit a special 510(k) to update the model.
 

QuinnM

Involved In Discussions
For anyone are there details that could be shared, both for companies that have PCCPs and those who tried to have a PCCP.
 

Bev D

Heretical Statistician
Leader
Super Moderator
Is this “Predetermined Change Control Plan” like a “Master Validation Plan”?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
My suspicion is fda isn’t aware fully how ai is different.

For example you have a ten problem benchmark. For a release candidate it must score 70% or higher. Your initial release scores 80%. It only misses problem 9 and 10. A new model scores 90%. It solves 9 and 10 now but misses #5. It should be released but fda can’t wrap their head around patient #5 being worse.

Ai is just trained on data. Performance is aggregated. It’s possible to tweak the model but addressing item #5 isn’t a direct pathway.

If you have a learning model after 5 years its performance may be substantially better but for new companies looking to enter your market their performance metric is not state of the art. Its state of the art 5 years ago and fda may worry approving a similar device with much worse performance.
 
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