Bhupindar,
Well in all honesty the FDA only sees a "snapshot" of your design and development hopefully the final version going to market. As you can expect, especially with software, there are going to be changes 1 day ... 1 month after you get clearance of the device. The important aspect is to document everything internally according to your design control process, design changes, design reviews, change management, etc. If development are still changing aspects of the software, eventually you will need to submit the "finished version" to FDA. As the Agency is not sitting there in your company watching your activities, they only see a package of documentation of the 510(k) submission, this is more an professional aspect where you are sending in the 510(k) with the latest information reflective of the product that will be placed on the market. It is not really proving to FDA the validation is done, because the documentation you are sending to the Agency is your own reflection of validation activities that hopefully have been finalised at one point. The FDA is not going to ask, 'Is this your final validation?' because they will assume what you submitted under the 510(k) application is your product intended for market. At some point you have to cut off your development group to get validation documentation to submit and hopefully manage them to hold off changes through the 510(k) submission process as this makes it even more complicated. As a final note, remember your organisation must sign the Truth and Accurate statement, so talk with your management and development group about what that actually means.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 20-Aug-2019 11:00
From: Loganathan Kumarasamy, MS RAC
Subject: Software Changes while Validation study in progress
Hi Bhupinder, How is the Validation process controlled? I believe you have change Control and proper version control in place on the product? If there is a continuous change, do you anticipate to do a code freeze to release the software into the market?
You will have to demonstrate a complete validation package on the software to provide it works as intended. If you have multiple revisions, it is fine as long as you have the impact assessment and validation approach defined within the complete package that proves that the software is validated.
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Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
Original Message:
Sent: 20-Aug-2019 10:22
From: Bhupinder Singh
Subject: Software Changes while Validation study in progress
Hello RAPs Community,
I am working on a Class II (510(K) not submitted yet) SaMD. Product validation study is on going right now. Software Developers keep on making the changes to the product (Enhancement/Security). I felt that these changes will impact the Product. Even though we have establish the change control process, all enhancement/ security updates will go through this process ( Impact on documentation, testing, code check in/out etc.)
My question is this how do I prove to the agency that validation is done on the final device. As per FDA, Validation need to be conducted on the final configuration of the device.
Please provide insight or suggestion on how to go over this issue.
Thanks,
Bhupinder Singh
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Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
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