Legacy Product - Do we need follow QSR 820? Design Verification and Validation

Ronen E

Problem Solver
Staff member
Moderator
#11
I didn't say that. I said:



Which is substantially what you said:
Yes, but please read on:

To me, that means that in cases where 820.30 applies, the foreign manufacturer has to have and follow the relevant procedures from that time onwards
What I wanted to stress is that it doesn't apply retroactively, i.e. any design process that took place prior to the marketing commencement date would not be subject to 820.30. It's not only a matter of determining which rules apply; it's also a matter of determining their scope of application (and particularly with regards to time).

I might have misunderstood you before and we may actually be saying the same thing - that's not a bad thing :)
 
Elsmar Forum Sponsor
M

MIREGMGR

#12
What I wanted to stress is that it doesn't apply retroactively, i.e. any design process that took place prior to the marketing commencement date would not be subject to 820.30. It's not only a matter of determining which rules apply; it's also a matter of determining their scope of application (and particularly with regards to time).
We may be nearly on the same wavelength in some respects, but consider this common scenario: I have a new US FDA Class II product idea, which I proceed to design. It hasn't yet been approved for marketing and I'm not marketing it yet, but after I complete the design I'm going to prepare a 510(k). Do I need to follow design controls in the pre-marketing design phase in order to have the requisite documentation for that 510(k) to be accepted, and to pass an early inspection in relation to that 510(k) if in some eventuality such an inspection should be conducted, as sometimes is the case internationally?

I think the answer is yes. If it were no, the great majority of Class II products would be subject to design controls only after they are designed. That, I'm pretty sure, is not US FDA's interpretation of the relevant provisions.

Maybe US FDA doesn't require/expect design controls for products that are designed more than X time before marketing begins, with X being a relatively long time. I've never seen any indication of such a policy in my pre-marketing-approval interactions with US FDA, though.
 

Ronen E

Problem Solver
Staff member
Moderator
#13
We may be nearly on the same wavelength in some respects, but consider this common scenario: I have a new US FDA Class II product idea, which I proceed to design. It hasn't yet been approved for marketing and I'm not marketing it yet, but after I complete the design I'm going to prepare a 510(k). Do I need to follow design controls in the pre-marketing design phase in order to have the requisite documentation for that 510(k) to be accepted, and to pass an early inspection in relation to that 510(k) if in some eventuality such an inspection should be conducted, as sometimes is the case internationally?

I think the answer is yes. If it were no, the great majority of Class II products would be subject to design controls only after they are designed. That, I'm pretty sure, is not US FDA's interpretation of the relevant provisions.

Maybe US FDA doesn't require/expect design controls for products that are designed more than X time before marketing begins, with X being a relatively long time. I've never seen any indication of such a policy in my pre-marketing-approval interactions with US FDA, though.
:applause:

Yes, this is quite what I meant. I don't have any formal indication regarding the length of X, but I think assuming it won't be less than a year would not be unreasonable. I also assume a solid (documented) market experience in a similarly regulated market (say, GHTF founding members) would count for something.
 
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