DMR-Device Master Record vs DHF-Design History File vs DHR-Device History Record

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L

Laura Halper

#33
The FDA uses and defines the term "Device History Record". I would guess that "Lot History Record" is just an in-house term for the same record. If the Lot History Record includes manufacturing and inspection records that show that the requirements of the Device Master Record (e.g., specifications, drawings, formulations, acceptance criteria) were met for a particular lot, then it is functioning as the Device History Record.
 
L

Lulumathew

#34
I was searching for the list of artifacts required for FDA/CE filing and I came across this terminology Lot History Records for Production equivalents.
 

Ronen E

Problem Solver
Staff member
Moderator
#35
I was searching for the list of artifacts required for FDA/CE filing and I came across this terminology Lot History Records for Production equivalents.
Sounds strange. :confused:

If by "filing" you refer to premarket clearance, then AFAIK both FDA and the EC system don't require specific lots records (i.e. in a 510k submission or a technical File).

If you referred to something else, plaese clarify.

Cheers,
Ronen.
 
P

potato124

#36
I think it depends on the organization. Here is how I would recommend thinking about it:

DHF: proof that the design and manufacturing are safe (basically 510k + process validations)

DMR: recipe on how to make the device (work instructions, routers, BOMs, etc)

DHR: proof that you made the product correctly for a specific lot
 
M

MFerguson

#37
First of all - apology for being a newbie to this forum.

From an activity perspective - we have collaboration tasks, we have interim drafts, we have interim review minutes, we have release documents (including the change request form + release approvals).

Questions - for the formal 'DHF'
1 - are all items - including the interim drafts and collaboration tasks included in the DHF?
or
2 - formal DHF is limited only to the release files and the signed release approval request?
and
3 - do we continue to show prior release history, or, DHF should be latest current release only?

And depending on answers - what hard-copy records need to be preserved? (we are a small start-up and could not afford the elegant on-line doc records like a GrandAvenue).

Thx & help
[and apology if posing question in the wrong thread...]
 

sagai

Quite Involved in Discussions
#38
My opinion would be:
1., not necessarily
2., could be
3., release history should be part of the DHF, the latest released design to production is more like a DMR for me.

I think, one extremity could be is that you keep only a one page document listing all the document references those relate to the design of the final release of your device design and a single signature manifest that all documents approved and the design was authorized to be released.

But, that's purely an opinion, you should work out your own way.

Cheers
 

Aphel

Involved In Discussions
#39
Hello!

How do you handle service reports (records according ?820.200) in regard to DHR?

The regulation does not require, that service reports are part of the DHR - am I right?

Best regards,
Aphel
 
M

MIREGMGR

#40
I assume you're going to save the records in any case, since 21CFR 820 establishes a requirement that the records exist and thus a basis for their inspection, and doesn't state a retention/disposal requirement which leaves you with the default life-of-the-product one. Given that, does it matter what legacy FDA term you apply to the record type? All FDA-required records are allowed to be kept on a distributed basis, as long as they're acceptably controlled and retained. Whether an inspector or auditor thinks your service records are part of the DHR, or maybe the DHF, or freestanding, you're good; they're in this file cabinet here.
 
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