Timing of 510k submission

MikeKilkelly

Starting to get Involved
#1
What is the earliest stage in device development that one can submit a 510k.
I would be grateful for any comments or experience.

Does the device have to be fully transferred to production and ready for shipping?
 
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shimonv

Trusted Information Resource
#2
This depends in a lot of things... like your device classification, what is ready and what is not ready, and so on.
Regarding design transfer, I would say that if your product is a class II device - you don't have to complete the transfer at that time of submission, but obviously it has to be completed before market access. Transfer, as you may know, may occur in several stages.

Hope this helps.

Shimon
 
Last edited:

MikeKilkelly

Starting to get Involved
#3
Thank you Shimon,
It's a Class II device (Medical Electrical Equipment). All safety testing has been completed but I'm wondering if all verification and validation testing needs to be completed before the submission or if it can continue in parallel while submission is being reviewed.
 

shimonv

Trusted Information Resource
#5
All safety testing has been completed but I'm wondering if all verification and validation testing needs to be completed before the submission or if it can continue in parallel while submission is being reviewed.
Like Ronen wrote, you don't have to be at 100% V&V complete for submission. You'll need to look at your design and development deliverables list and cross check it with the 510(k) content list and FDA's Refuse to Accept checklist. It will be a nice exercise for you :)
 

mihzago

Trusted Information Resource
#7
Any V&V testing that is part of the submission, i.e. data used to demonstrate safety and effectiveness must be completed. All risk controls must be completed and verified.
It used to be that FDA would allow some of the validation testing, like long term compatibility, or safety/electrical testing done by a third-party lab, to be finished while the submission was under the review, but that is no longer the case.
 

Watchcat

Trusted Information Resource
#8
It's not about a stage in development, it's about demonstrating substantial equivalence.

It's not about when you "can" submit, but when it makes good business sense to submit.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Any V&V testing that is part of the submission, i.e. data used to demonstrate safety and effectiveness must be completed. All risk controls must be completed and verified.
It used to be that FDA would allow some of the validation testing, like long term compatibility, or safety/electrical testing done by a third-party lab, to be finished while the submission was under the review, but that is no longer the case.
That's quite a sweeping statement. I think that "the FDA" is not that uniform or consistent.
The specific elements you mentioned are part of verification IMO, and I agree with you that verification has to be complete before a 510(k) submission can be seriously considered.
Demonstrating substantial equivalence is mostly about the "pure" design, i.e. it doesn't have to fully address a specific manufacturing setup. Validation typically involves serially manufactured units, and hence typically comes after the design is already available at a level enabling demonstration of substantial equivalence.
 
#10
Any V&V testing that is part of the submission, i.e. data used to demonstrate safety and effectiveness must be completed. All risk controls must be completed and verified.
It used to be that FDA would allow some of the validation testing, like long term compatibility, or safety/electrical testing done by a third-party lab, to be finished while the submission was under the review, but that is no longer the case.
Additionally, you need to be finished with all performance testing that shows your device is substantially equivalent to the predicate if you are going thru the 510k pathway,
 
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