DHR (Design History Record) Requirements - Concessions

[Mondo 22]

Thanks for your input Marcelo.

it would be interesting to hear how other people approach this in thier companies.

[MIREGMGR]

My view is that every unit of medical device product that is subject to US FDA jurisdiction must be accounted for in the DHR, and that accounting per (d) must include either a record of conformance or a record of accepted non-conformance ("concession").

I'm reasonably sure that such an interpretation was FDA's intent.

Note that QSR records may be composite rather than unitary. Thus the "master concessions...central file" may be regarded as part of your DHR if you so choose...but of course that designation would have to be consistent, and that central file otherwise treated as a controlled QSR record of DHR-level importance.

[Mondo 22]

At my last company we weer subjected to an FDA inspection, the inspector reviewed 7 DHR's and the Concession master file seperatley and no comments were made.

But could this vary depending on the inspector?

[Ronen E]

It may be of interest to note that the preamble to the 1996 publication of part 820 on the Federal Register stated:

iii. Device History Record (§ 820.184)
(...)
One comment stated the requirement should be amended because it explicitly requires that dates and quantities for each batch be in the DHR, while only implying through the general requirement that the DHR must also contain the batch test data.
(...)
FDA agrees with the last comment and has added in § 820.184 ‘‘(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR’’ to explicitly state the requirement to avoid any confusion.

I take this to say that the FDA's initial intention in issuing § 820.184 (d) was merely to require the inclusion of batch test data in the DHR. Any concession later granted by the manufacturer to a non-conforming product, and any associated reasoning, would not, IMO, count as data and therefore would not be covered by this requirement.

[sridharafep]

For a good system - you need to have history. But if your process records it in some or other way then you can avoid duplicate.