Updating DHF (Design History File) to include Alternative Component

E

ElmerF

#1
Hi All,

I have a medical device (510K) that contains a delivery component. There are other parts within this product also. The product has completed Design Transfer to production and is contained in Design History File 1 (DHF1). Subsequently we created DHF 2 which was a minor design change to this delivery system and completed Design Transfer to production. The change was a note to file and did not require a new 510K. These devices have different product codes and both are still commercial. We now have a supply issue with delivery component from DHF1. Can I update DHF1 to change to DHF2 delivery component with note to file and updates to DHF1 while keeping DHF1 product code? (Appropriate testing has been completed for compatibility/Design verification etc). Also is there any way to make DHF2 delivery system an alternative component rather that a replacement. I am having difficulty seeing how you can accommodate a change to the DHF1 documentation while keeping the earlier revision component also.

Manufacturing want to be able to use either delivery component depending on supply. There are some minor differences in the device specification for the delivery component. Device specification would require updating. Given the updates required to the Design History file to reflect the new specification is there any way to maintain both as part of the same DHF? Both would also need to maintain the same DHF1 product code for customers but would be differentiated by part number in manufacturing. (We need to keep the same product code as hospitals won't change approved codes on their system.)

Appreciate any input you can give.

Thanks,

ElmerF
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

In my opinion the DHF shouldn't be your number 1 concern. You should be more concerned about the DMR, consequent DHRs, configuration control and postmarket traceability. I'm not aware of a regulation that should prevent you from running interchangeable configurations on the same model number provided that the details are well documented and you have good control and traceability. Perhaps run (and document) a risk management session considering "what could go wrong" from the moment an inquiry is received, through quoting, ordering, production, billing, supply, post-market surveillance, adverse events reporting and recall.

The DHF is basically just a compilation of documentation generated through the design process. You should keep in there the documentation of design work that led to the new configuration and any changes made to the old version to allow for interchangeability; the design verification test reports; any validation and design transfer documentation; any letters to file or justifications why a new 510(k) is not required; and the risk management that shows you have considered all relevant aspects and addressed the identified risks properly. I wouldn't worry too much about model/configuration numbers in the DHF, as long as it's made clear what configuration each document relates to. You can pretty much keep it all in one file, provided that you can locate each element in a timely manner should an FDA reviewer / investigator ask for it.

HTH,
Ronen.
 
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