How to make risk analysis for design changes to existing devices

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celia4237

#1
When submiting the special 510(k), We came across some problems.

(1) Lack of risk analysis to assess the impact of the modification on the device and its components.
(2) Lack of the required verification and validation activities and the acceptance creiteria.

I have go through the ISO14971 as well as the guideline document of design control from FDA. But no solutions to these problems.

Can anyone give me some examples about solutions to these problems?
 
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M

MIREGMGR

#2
Re: How to make risk analysis to the changes to exsiting devices.

With regard to risk analysis, well...you do such an analysis. 14971 provides a pretty comprehensive discussion of the general analytical technique. Obviously you need to have a comprehensive knowledge of how your device is intended to be used, and might be mis-manufactured, mis-used, etc.

Perhaps more specific suggestions would be possible if you would identify the FDA product classification code ("ProCode") of your device. Did you get specific examiner feedback that he or she wants a risk analysis?

Verification (did you design and make the device right?) and validation (did you design and make the right device?) are fundamental. Were there examples of each documented in the Traditional 510(k) to which your Special 510(k) is referenced? Who created the specifications for the product...your firm, or an outside party? Who determined the medical need, and thereby the Intended Use? The specifications, medical need and Intended Use are obviously important elements in verification and validation.
 
C

celia4237

#3
Thank you for your response.

Our product is a blood pressure monitor. The only change is the addition of a voice function which is used to tell the result.

How to do the risk analysis? what kinds of design verification and design validation should we submit to FDA?

Thank you very much!
 

yodon

Staff member
Super Moderator
#4
Does the original device (blood pressure monitor without the voice function) have an established risk analysis and any design verification results?
 
C

celia4237

#5
I have just checked our report of risk analysis and the design file. Both of the two files are uncompleted.

What should i do under this situation.
 
M

MIREGMGR

#6
When was the Traditional 510(k) granted...was it under the same rules and interpretations that currently apply? It's been a long time since basic requirements for design verification and validation were added.

In any case, clearly you have some work to do...particularly if you already filed and the examiner gave you negative feedback, so now your revised submission will receive heightened scrutiny. None of us can do much to actually help get it done. You might as well get started.
 

yodon

Staff member
Super Moderator
#7
As MireMgr says, you have some work to do! One avenue would be to hire a consultant to help guide you through the process. I would probably recommend this since you are having trouble getting started.

The other avenue is to roll up the sleeves and get to work. I'm just guessing, but I presume the device is Class II with a minor level of concern for software. As has been said before, though, everything needs to be framed around the intended use. 14971 gives you the information / guidance to put together a solid risk assessment. You should be able to find plenty of info on design verification and validation through searches here in the cove. Of course, it takes time to find and distill all the information so if time is a concern (and where isn't it??), then you're back to the consultant route.
 

Al Rosen

Staff member
Super Moderator
#8
Do a search in the post attachments list using keyword "risk". There are a number of items that will be of help.
 
C

celia4237

#9
I have wrote to FDA for help. Here is the content and i hope more discussion.
...................................................................................................
"Dear Celia:
The risk analysis should really account for the whole device after the modifications have been made. If the risk analysis shows "no risk," then you would not need to submit design validation and verification. I hope this is helpful.
------------------------------------------------------------------------------------------------------------------------

Hi:
We have met problem as follows, when submitting the special 510(k)


" [FONT=&#23435]The information you have provided on your design control activities is not sufficiently detailed. Therefore, please provide a more specific and detailed information on your design control activities.


[FONT=&#23435]
[/FONT]

[FONT=&#23435] A An identification of risk analysis methods used to assess the impact of the modification on the device and its components.
[/FONT]

[FONT=&#23435]
[/FONT]

[FONT=&#23435] B The results of the risk analysis, e.g.,the specification, and whether the device passed or failed.
[/FONT]

[FONT=&#23435]
[/FONT]

[FONT=&#23435] C Based on the risk analysis, an identification of:
[/FONT]

[FONT=&#23435] [/FONT][FONT=&#23435] the required verification and validation activies, including the methods or tests used, and
[/FONT]

[FONT=&#23435] [/FONT][FONT=&#23435] the acceptance criteria to be applied.
[/FONT]

[FONT=&#23435] D A declaration of conformity with design controls. [/FONT][FONT=&#23435][/FONT]
[FONT=&#23435]The question are: the risk analysis should be on the whole device, or just on the changed part of the medical device? If the result of the risk analysis shows that no risk should be controlled, Do we need to submit the design verification and the design validation? [/FONT]
[FONT=&#23435] celia [/FONT]

[FONT=&#23435]
[/FONT] ..........................................................................................................................
[/FONT]

 
C

celia4237

#10
I have just finished my document of risk analysis, and i know there must exsit some problems in this document. I hope someone who could give me some suggestions.

And i really want to learn something.

Thanks a lot.
 

Attachments

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