What results of a design review are documented in a DHF, as they shall be used in medical device industry, to be FDA compliant?
Should all comments, issues which are made by the reviewers, be documented, or is the modified and committed / approved document, which is reviewed, sufficient?
Who can help me out?

What results of a design review are documented in a DHF, as they shall be used in medical device industry, to be FDA compliant?
Should all comments, issues which are made by the reviewers, be documented, or is the modified and committed / approved document, which is reviewed, sufficient?
Who can help me out?According to 21CFR820.30(e) in part: The results of a design review, including identification of the design, the date and the individual(s) performing the review shall be documented in the DHF. That is what is required. If you have minutes of a meeting or another document that includes these three items, that is what you need to comply.

:truce: Pardon the ignorance, but what's a DHF?

:truce: Pardon the ignorance, but what's a DHF?Sorry. It's a Design History File.

Sorry. It's a Design History File.

Thanks. I learn something here just about every day.

Thanks Al for your reply.:)
So may I conclude that the total list of individual comments from each single reviewer is not needed, according to the FDA?

What we currently use, is:
1) The document to be reviewed;
2) The updated document as a result of the review (with a notification about the review in the document history part)
3) A review report.
4) a defect list, listing all individual comments.

So the defect list is not needed to be stored in the DHF?

Pierre

Thanks Al for your reply.:)
So may I conclude that the total list of individual comments from each single reviewer is not needed, according to the FDA?

What we currently use, is:
1) The document to be reviewed;
2) The updated document as a result of the review (with a notification about the review in the document history part)
3) A review report.
4) a defect list, listing all individual comments.

So the defect list is not needed to be stored in the DHF?

PierreIs this a design review of a new project or is this a review for a change to an existing device? There are other considerations.

It is a design review of a new release of a software package, which is being built in into a medical device.
The design is extended with new functionality.

Hope this helps!

Regards,

Pierre

It is a design review of a new release of a software package, which is being built in into a medical device.
The design is extended with new functionality.

Hope this helps!

Regards,

PierreYou should look at the FDA GuidanceDocuments, General Principles of Software Validation (http://www.fda.gov/cdrh/comp/guidance/938.html)and Design Control Guidance For Medical Device Manufacturers. (http://www.fda.gov/cdrh/comp/designgd.html)

I believe problems and issues that come up during design review need to be resolved, closed and be part of design review doc and added to DHF.