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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
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