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FDA expectation of Concessions - Changes to a DMR

S

s.parakos

#1
I am curious how other members handle changes to a DMR:
Do you create a Concession for ANY document change in the DMR?
I understand that the purpose of Concessions is to allow manufacturers to keep selling product with minor nonconformities. But once a Device is released does the FDA expect to see any changes in a DMR recorded as a concession?
I can imagine changes to documents which improve manufacturing for instance, but do not change the form, fit or function - how do people handle these?
Or how about a minor typo in a Device Manual - technically a change in form?

thanks
Simon
 
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Al Rosen

Staff member
Super Moderator
#2
I am curious how other members handle changes to a DMR:
Do you create a Concession for ANY document change in the DMR?
I understand that the purpose of Concessions is to allow manufacturers to keep selling product with minor nonconformities. But once a Device is released does the FDA expect to see any changes in a DMR recorded as a concession?
I can imagine changes to documents which improve manufacturing for instance, but do not change the form, fit or function - how do people handle these?
Or how about a minor typo in a Device Manual - technically a change in form?

thanks
Simon
A concession is something that you allow to be used without making a change. It is temporary. Permanent changes to your product should be handled in accordance with your system for design changes. Typos can be handled according to your document control procedure.
 
S

s.parakos

#3
Hi Al,

Thanks for your reply.
If product / process changes are made in accordance with our QMS procedures for design changes and controlled documents, do we then have to create a new DMR?
How static / dynamic can a DMR be?

regards
Simon
 

Al Rosen

Staff member
Super Moderator
#6
No, I understand that, but I was under the impression that the DMR was a static set, and any changes to it require either a Concession or the closure of that DMR and the creation of a new one.
I don't understand why a Device Master Record would be static. The DMR is a collection of documents. You might make revisions to the documents and you might add documents to the DMR. You would then control these changes either through Design & Development or Document Control procedures. Can you give me an example of when you would create a new DMR?
 
S

s.parakos

#7
Thanks, you have cleared that up for me.

I received some mis-information, or more likely, misinterpreted what I was being told.

Simon
 

Weiner Dog

Med Device Consultant
#8
Hi. I worked as an FDA investigator (Level II Certified International Medical Device Investigator) for over 21 years- primarily in the medical device arena. Currently, I am a contract international medical device consultant for hire.

As far as FDA and the QSR are concerned, any change to a specification, label, process, product, software, or procedure is a change and has to undergo change procedures according to various 21 CFR 820 sections, including 820.30(i), 820.40(b), and 820.75(c).

Do you understand when to use 820.30(i) and/or 820.75(c), even if you are changing a written procedure under 820.40(b)?
 
S

s.parakos

#9
Do you understand when to use 820.30(i) and/or 820.75(c), even if you are changing a written procedure under 820.40(b)?
Yes we control all of our design changes and keep appropriate records. A DMR only gets updated once the change has been approved.

Simon
 
Last edited by a moderator:
R

Regulatory

#10
We are also doing the same thing...we control all of our design changes and keep the records...!

I agree with that..................

Thanks Simon for the answer!
 
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