Regulatory Open Forum

Hello,

Our company currently has a Class III IVD device in review with the FDA, currently we do not have approval. While we wait for an approval, we are starting design changes to be ready for a supplement submission once approved. Our product development team has decided to put in a design change request but will handle the design changes as a new project starting at Phase 0, treating all the changes as if it's a new product. Therefore it will have its on DFH, DMR, and DHR. This seems odd to me as we've always updated design changes under one DFH, DMR, and DHR, I've never seen it done this way. Doesn't mean it's wrong just curious if anyone else has experienced this and if it was a good or bad road to go down. Thanks! 

Hello Anon,

Companies do indeed implement design changes this way by creating a "new" Design History File (DHF) or design records.  There are different ways either appending an existing DHF or creating a completely new DHF can be managed, I would not say there is one way better than the other.  For me, it is more about management of the design records, which is more efficient based on the quality system or the type of device.  In addition, think of how the information is presented during an inspection or audit, again sometimes it is easier to show a separate file for each design iteration, but it may also be easier showing the chronological or updating pathway a device took.  Personally, I like having a separate file or semi-separate file for each major design change, it is easier to see during reviews.  But the issue which then gets raised it what happens to all the minor or small design changes along the way ... there are different ways it can be done - really up to each organisation on how they manage the documentation.

Hello,

Our company currently has a Class III IVD device in review with the FDA, currently we do not have approval. While we wait for an approval, we are starting design changes to be ready for a supplement submission once approved. Our product development team has decided to put in a design change request but will handle the design changes as a new project starting at Phase 0, treating all the changes as if it's a new product. Therefore it will have its on DFH, DMR, and DHR. This seems odd to me as we've always updated design changes under one DFH, DMR, and DHR, I've never seen it done this way. Doesn't mean it's wrong just curious if anyone else has experienced this and if it was a good or bad road to go down. Thanks! 

Hello,

Our company currently has a Class III IVD device in review with the FDA, currently we do not have approval. While we wait for an approval, we are starting design changes to be ready for a supplement submission once approved. Our product development team has decided to put in a design change request but will handle the design changes as a new project starting at Phase 0, treating all the changes as if it's a new product. Therefore it will have its on DFH, DMR, and DHR. This seems odd to me as we've always updated design changes under one DFH, DMR, and DHR, I've never seen it done this way. Doesn't mean it's wrong just curious if anyone else has experienced this and if it was a good or bad road to go down. Thanks!