DHFs / D&DFs for Older Products -- Responses to Questions from My Recent Webinar
QUES: I have been tasked with a project to remediate the DHFs of all our CE-marked products. This arose from a finding in our audit with our Notified Body. First, having watched your presentation, it seems strange now that our NB would issue a finding on our DHFs when they have already accepted our Technical Files. Do you know why they would push us on the “history of development” aspect when the requirement for the Technical File is just “a point in time”?
ANS: As I mentioned in my webinar, I defer to N-B's on specifics for CE marking. So I'd recommend that you run your proposed solutions by them. With that said, my own rationale on your question: The DHF is an FDA CGMP term and requirement (21 CFR 820) since 1996-7 as you also stated. The Tech File is a EU / CE-marking requirement, which also requires a section on Design Control, presumably now in accordance with ISO 13485:2016's 7.3 Design and Development Planning (and File), which D&DF is basically the same as the DHF, and proof of compliance to 820.30 or 7.3's 10 requirements. I have in the past addressed that, as mentioned in the presentation, with a copy of the Des Cont SOP added to the Tech File, existing at the time of the Tech File audit, together with and a description as to how all its requirements were met in the design / development of the product (and referencing the applicable DHF).
QUES: Second, some of these products were originally developed in the 1960’s or even 50’s. Given the requirement on Design Control was instituted in 1996, can we use that as a cutoff point for documentation in the DHF? I’ve reviewed the paper files in storage and a few of them go back the 1980’s, but nothing dates back to the actual origin of these devices. That also presents a problem for defining the start date you promoted. Any suggestions on how to address that?
ANS: It presents a problem across the board. Certainly you could use 1996/7 as the cutoff date for the requirement for a DHF. You could address that by your Design Control / Design and Development Planning SOP, which could discuss how your company will provide for "grandfathered" devices. I mentioned that some companies develop such files for older products anyway as an attempt to capture any available history prior to it all disappearing with personnel retirements, etc. If your N-B wants a DHF/ D&DF no matter what, this is the approach I'd take. Obviously such DHFs / D&DFs would be very abbreviated with a fairly short narrative as to approximate time of acquisition, method of acquisition (in-house, purchase, contract ...) and any other information so obtained, how obtained, refer to the Design Control SOP on "grandfathered product" and similar, signed and dated by QA ...
And device changes since 1996/7 on older / grandfathered product, require such files to be developed (with such older products) or amended (with post 1996/7 products). Another alternative is to develop DHFs/D&DFs for all the older products, with whatever data you're able to capture (I use old lab books, 510(k)s, some companies actually had Project History Files as their own requirement for product development history before it was a regulatory requirement ...) and have an explanation as to why this approach is being taken -- the FDA's history of Design Control starting in 1996/7, and these products predate that. You may be able to find out some basic data how products were developed (or acquired) by your company for any old documents still available, interviews with retirees or others, current methods which may not have changed much, etc.
Start date unknown: Obviously "start date" is for a current project (the actual reason for design control), and could also be recorded for a retroactively developed file from recent history. As I mentioned, I often am called in to address a 483 and retroactively compile a DHF, but this is for products developed after 1996/7, and all that background and reason for the retroactive compilation is stated in a cover document / narrative, including the reason for any omissions.
QUES: Finally, are paper DHFs still common and/or preferred? Various people in our organization have been pushing for scanning the remaining paper and using all-digital storage.
ANS: I still see a lot of paper DHFs, but the trend is to electronic records. In which case, the system and records / signatures used for such a record / file retention system must be validated, including to 21 CFR 11.