?820.30(d) Design Output Release - Before or After Verification?

A

Andress2

#1
§820.30(d) Design Output Release - Before or After Verification?

Hello,

If this is a no-brainer to you, then I apologize upfront :) but it so happens that I am a bit puzzled right now by the requirements of FDA 21 CFR §820.30(d):
Design output obviously needs to be documented, reviewed and approved before release (or transfer to the next design phase, I assume). How does this relate to verification in terms of timeline? Since I need to ensure that my output is meeting the design input requirements I established, is it not appropriate to initiate verification activities on this specific output BEFORE I approve the output? If this is not the intent, what is the value-add or purpose of approving design output before release?

My company currently maintains a strict separation between approval of design output and verification activities.

Thanks for sharing your thoughts!:agree1:
 
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sagai

Quite Involved in Discussions
#2
Re: §820.30(d) Design output release - before or after verification?

Hi Andress2!
I do not think there is any definition saying to you when you have to have an approved design output other then the end of the Design and Development phase, and that is for me equivalent with the time before Design Transfer occurs.
The content of your Design Output actually also the result of your V&V activities, please see:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm
It not a caveat, you can have interim design outputs, and u use those interim design outputs to do your V&V activities.
Cheers!
 

Sam Lazzara

Trusted Information Resource
#3
Re: §820.30(d) Design Output Release - Before or After Verification?

Since the device itself (and the corresponding Device Master File/Device Master Record) is the design output, and you need the device to perform design verification testing/analysis, I think you should approve the design output BEFORE verification. This is not to say that the design output will not be revised throughout the product life cycle.

My practice is to require the DMF/DMR to be released at some level in the document control system BEFORE initial verification. That way, document change controls will be in place so you can subsequently determine whether changes require re-verification.

DESIGN OUTPUT: The results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record. (FDA 21 CFR 820)

Side Comment - It is a misnomer to ever say a medical device design is "frozen". You need to document your baseline Revision "A" design and continually evaluate changes to consider the impact on previously performed design verifications/validations and process validations.
 
Last edited:

sagai

Quite Involved in Discussions
#4
Re: §820.30(d) Design Output Release - Before or After Verification?

We are drifting to slippery fields now :)

I am not quite sure if there is anything referred as Device Master File in the QSR, what is that for?

I think Design Output, Design Verification documentation, DMR are only different angles on the documentation expected to create.

I do not think Design Output can be finally released before design verification because of its very nature, it shall include the result of the verification and of course there are references that are likely not exist as a final release at the time before verification starts.

The intent of releasing DMR before design verification is rather vague for me and again, I do not really understand the benefit, I believe releasing DMR just as part of design transfer is okay.

Cheers!
 
#5
Re: §820.30(d) Design Output Release - Before or After Verification?

Hello,

If this is a no-brainer to you, then I apologize upfront :) but it so happens that I am a bit puzzled right now by the requirements of FDA 21 CFR §820.30(d):
Design output obviously needs to be documented, reviewed and approved before release (or transfer to the next design phase, I assume). How does this relate to verification in terms of timeline? Since I need to ensure that my output is meeting the design input requirements I established, is it not appropriate to initiate verification activities on this specific output BEFORE I approve the output? If this is not the intent, what is the value-add or purpose of approving design output before release?

My company currently maintains a strict separation between approval of design output and verification activities.

Thanks for sharing your thoughts!:agree1:
Design Input >>> Design Output
Design output that comes first to meet the Design inputs are necessary
Necessary for what ? Not for release >>> but
For review, leading to changes if necessary, then to verify, and to validate.....
and then you again have the
Design Output, that is fit and good for release to the best of your inputs., reviews., verifications and validations.
And the later changes are addressed through design change process >>>
 

Sam Lazzara

Trusted Information Resource
#6
Re: §820.30(d) Design Output Release - Before or After Verification?

Yes this is "slippery" stuff....hence this forum.

The term "device master file" is my term for the ISO 13485 equivalent of FDA's "Device Master Record" and Japan's "Seihin Hyojunsho".

US FDA 21 CFR820.3(j) Device master record (DMR) means a compilation of records (ugghhh) containing the procedures and specifications for a finished device.
Note: That is my "ugghhh".

ISO 13485, 4.2 Documentation requirements, 4.2.1 General
For each type or model of medical device, the organization shall establish and maintain a file either containing or identifying documents defining product specifications and quality management system requirements (see 4.2.3). These documents shall define the complete manufacturing process and, if applicable, installation and servicing.

It has always bothered me that the FDA term includes the word "Record" - this causes lots of confusion. To me it is a set of documents that are not of the record-type. This gets further confounded since the ISO 9005:2005 definition for document includes records as a special type of document - another potentially confusing aspect of all these words.

ISO 9000:2005
information = meaningful data
document = information and its supporting medium
EXAMPLE Record, specification, procedure document, drawing, report, standard.
record = document stating results achieved or providing evidence of activities performed

Note: FDA's "Device Master Record" does not state results achieved!

The guidance for ISO 13485 is ISO 14969. Here are some excerpts:

4.2.1.4 The file for each type or model of medical device referred to in ISO 13485:2003, 4.2.1 is sometimes referred to by different terms (see Annex A, section B). This file can contain, or give reference to the location of, documentation relevant to the manufacture of that product. Examples of such documentation can include
— specifications for raw materials, labeling, packaging materials, sub-assemblies, and medical devices,
— parts lists,
— engineering drawings,
— software programs, including source code (if available),
— work instructions, including equipment operation,
— sterilization process details, if applicable,
— quality plans,
— manufacturing/inspection/test procedures, and
— acceptance criteria.

4.2.1.5 The documentation referred to in ISO 13485:2003, 4.2.1 forms part of the quality management system and should be subject to document and record control procedures (see 4.2.3, 4.2.4).

-----------------------------
Back to my main point. If you do not approve/release the documents that describe the product - the design output documents - how do you know what you tested/verified?
How else can you justify the need (or lack of need) to perform new testing based on future changes after the initial/baseline verification work is completed.
 

sagai

Quite Involved in Discussions
#7
Re: §820.30(d) Design Output Release - Before or After Verification?

Hi,
I have similar doubts and "ugghhh"s :) . Furthermore I truly like to see the different angles on subjects we have here.

I do not fully like the DI>>DO way of thinking, there are products when that strict sequential design simple does not work, or we can believe that is the way, but the people very much not working accordingly due to very obvious reason, they have to accomplish time to market objectives.

Actually, I have excluded ISO, original poster referenced the QSR only.

The only thing I have tried to point out, that I think prior design transfer we simple can not claim, that we finally approve the design output because of its very nature that the content of the design output is broader than the artifacts we have at the beginning of the design verification. And in order to be in-line with the terminology of the QSR (+design control guidance, I have already shared the link to it) we may need to consider distinguished terminology (like interim design output, or anything different) for the bunch of artifacts we intend to approve prior design verification.
Cheers
 
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