Finishing Design Validation per 21 CFR Part 820

[Aphel]

Hello,

Actually I am dealing with a really nice topic...design validation... :/

My question is...according to your development procedures, when has
design validation (820.30g) to be finished? Before or after regulatory approval/clerance/submission? Before or after CE marking? Before or after market release?

Thank you very much for your thoughts!

Best regards,
Aphel

 

[sreenu927]

Re: Finishing design validation

Hi Aphel,

All the DHF elements such as Design input, output, review, Verification and Validation, transfer must complete before the regulatory file submission either 510(k) or CE Marking.

For registration filings, one of the documents required is design validation test report.

Hope this clarifies your doubt!

Regards,
Sreenu

 

[sagai]

Re: Finishing design validation

I would say differently.
Design validation needs to give a necessary confidence to decide that you will market your device and you satisfy the legislations, however the marketing of the device does not necessary should stop you to carry on with the validation.
Cheers!

 

[Marcelo]

Re: Finishing design validation

Before approval, including CE marking, and market release. You have to finish one iteraction of validation (meaning, you have to conclude the device conform to needs) before all that, because regulations require that.

However, as Sagai mentioned, validation is recurrent.

One way to think of it is:

Premarket - the question you ask is - is the device created to be safe and effective?

Post market - is the device really safe and effective, meaning, the post market confirm that your initial validation (and other things) is ok, or you need to revalidate, or reverify, or reintroduce safety, or any other.

 

[Aphel]

Re: Finishing design validation

Thanks Marcelo!

You said:

"Before approval, including CE marking, and market release. You have to finish one iteraction of validation (meaning, you have to conclude the device conform to needs) before all that, because regulations require that."

Which regulation requires exactly requires finishing design validation before the CE marking? Thanks a lot!


I have another question...
From your point of view, does it make sense to link validation of usability (IEC 62366) with design validation activities?

Best regards,
Aphel

 

[Marcelo]

Re: Finishing design validation

Which regulation requires exactly requires finishing design validation before the CE marking? Thanks a lot!

No one really has such a sentence as you mentioned, but understanding the concepts of the regulations, it's clear what is required. For example, in the case of the medical devices directives, they really do not use the term validation (it's only written twice in the MDD, for example, but related to other stuff). However, the directives do require that you fulfill essential requirements (of safety and performance) before applying the CE mark. As part of the essential requirements deals with intended use, evaluation that the device fulfill,s the intended use is validation - MDD essential requirement 1.3, for example.

From your point of view, does it make sense to link validation of usability (IEC 62366) with design validation activities?

Yes, it's part of design validation - please note that validation activities do not need to be performed together, as your question seems to imply. Depending on device and design process ,you might need to perform several validation activities during the design process lifecycle.

 

[somashekar]

Re: Finishing design validation

Which regulation requires exactly requires finishing design validation before the CE marking? Thanks a lot!

CE mark aligns to EU regulation.
Clinical evaluation report is a very essential content and the crux of your technical file that is evaluated by your NB prior to CE.
You may be saying at several places in your ER response that clinical evaluation will be your way to address.
This (clinical evaluation) is your finishing design validation