L
Lancia
Hello Everyone,
I am new to the forum and the 510(k) process. I read a lot of your helpful threads but still have a few questions, if you don't mind.
For the past four months I've been collecting data for a 510(k) for a mobile med app and so far with lots of reading and samples was able to figure out the next step. But once I got to software validation I got lost - questions started to pile up. I am confused of the information that we need to have on file and the software part of the submission. Any help would be greatly appreciated.
So:
The quality regulations Title 21 - How do we go about it? I started reading it, but I do not understand if it is a series of procedures that we need to simply follow, or have to have a file with sections e.g. "Maintenance schedule", etc.? Is it actually something we can do by ourselves or need to hire a consultant?
The software validation - do I submit it in the 510(k) or do I have this on file? Is there a format for it? We do have software validation and verification procedures in place, but not sure if everything is logged or documented to meet FDA requirements. I'm so lost here, I don't know what is the right question to ask. There seem to be so many docs and guidance, that I'm not sure even if I am reading the right one.
Predicate testing - how extensive is it? How do I document the findings? Is there a format to follow? Or is the comparison table enough?
ANY help would be appreciated!
I am new to the forum and the 510(k) process. I read a lot of your helpful threads but still have a few questions, if you don't mind.
For the past four months I've been collecting data for a 510(k) for a mobile med app and so far with lots of reading and samples was able to figure out the next step. But once I got to software validation I got lost - questions started to pile up. I am confused of the information that we need to have on file and the software part of the submission. Any help would be greatly appreciated.
So:
The quality regulations Title 21 - How do we go about it? I started reading it, but I do not understand if it is a series of procedures that we need to simply follow, or have to have a file with sections e.g. "Maintenance schedule", etc.? Is it actually something we can do by ourselves or need to hire a consultant?
The software validation - do I submit it in the 510(k) or do I have this on file? Is there a format for it? We do have software validation and verification procedures in place, but not sure if everything is logged or documented to meet FDA requirements. I'm so lost here, I don't know what is the right question to ask. There seem to be so many docs and guidance, that I'm not sure even if I am reading the right one.
Predicate testing - how extensive is it? How do I document the findings? Is there a format to follow? Or is the comparison table enough?
ANY help would be appreciated!