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V&V for Special 510k

primavesvera

Starting to get Involved
#1
Greetings!

I am fairly new to this forum and I have searched through related topics, but I still haven't found my answer, so I'd appreciate if somebody could help me.

What am I dealing with: we have a FDA cleared device and the idea is to submit the new version of the device for Special 510k. I have slight confusion due to the fact that I (my position is within quality management area )need to prepare a document related to the design controls, but my boss doesn’t want to do verification and validation, since he thinks that validation is the pathway for Traditional 510k.

So, my question is – for the summary of design controls in the case of Special 510k, do we need to do both verification and validation of our new device compared to the predicate or we need to do only verification?

Thanks in the advance.
 
#2
Design controls include design verification and design validation are required for all FDA Class 2 and Class 3 medical devices (per 21 CFR 820) regardless of the regulatory submission type you choose.

The Special 510(k) allows the manufacturer to declare conformance to design controls without providing the data. However, design controls are required in full (all 820.30 requirements with no exceptions).

510(k) Submission Methods

Please tell your boss to not kill the messenger...
 
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