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

G

gxzn008

#1
we had a legacy product that finished design five years ago, and we got 510K two years ago.
Recently we were noticed that FDA will audit our site this April.

Now I have a concern for design control, do we need to finish design verification and validation activities etc like new NPI?

Or we need not care about this legacy product, we just need to make sure the DMR available?
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
You must demonstrate conformance with the rules that were applicable when the device was approved for marketing.

In some cases, you additionally may have to conform to rules that went into effect subsequently.

"Legacy" status would only excuse you from otherwise-applicable design control rules if you could prove that the product was marketed by you prior to 1976, when the current rules structure went into effect.
 

Michael Malis

Quite Involved in Discussions
#3
we had a legacy product that finished design five years ago, and we got 510K two years ago.
Recently we were noticed that FDA will audit our site this April.

Now I have a concern for design control, do we need to finish design verification and validation activities etc like new NPI?

Or we need not care about this legacy product, we just need to make sure the DMR available?

The short answer is a definite “YES”.
You should be concern with the status of design control and all your design verification and validations activities. FDA inspector will also check for any product modifications to make sure that changes were documented appropriately and did not require a new 510(k) submission.

Consider yourself lucky that you located outside US and received 3 months’ notice. Please use this time appropriately.

Regards,
Michael
 
G

gxzn008

#6
Actually we finished this product design activities very simple five years ago, so you mean we need to complete all the design documentation from design planning until to design transfer, it is a huge workload. :mad:

For design change,we had checked them to confirm if we need to submit special 510K.

So from your point of view, we still need to prepare all the design V&V documentation even though it is legacy product.
 
M

MIREGMGR

#7
Actually we finished this product design activities very simple five years ago, so you mean we need to complete all the design documentation from design planning until to design transfer, it is a huge workload. :mad:
Considering that if such compliance did not occur when the product was originally developed its subsequent marketing in the US has been illegal, doing the work to retroactively comply so that further US marketing is justifiable doesn't seem out of line to me.

The alternative would be to stop marketing the product, of course. Even then you might be cited during the FDA inspection for past illegal practices.

So from your point of view, we still need to prepare all the design V&V documentation even though it is legacy product.
I'm not sure what significance "legacy product" has to you. It doesn't have any significance to US FDA unless the product was marketed prior to 1976.
 

Michael Malis

Quite Involved in Discussions
#8
gxzn008,

Yes, you need to have updated V&V documentation. it should not be a "huge workload" if your company done the work 5 year ago.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Considering that if such compliance did not occur when the product was originally developed its subsequent marketing in the US has been illegal, doing the work to retroactively comply so that further US marketing is justifiable doesn't seem out of line to me.
Though this approach would definitely be "on the safe side", it seems a bit extreme to me. What if a device was developed by a non-USA manufacturer and marketed outside the USA, then 20 years later the manufacturer wishes to place it on the US market, submits a 510(k) and gets a SE letter - would you still say they have to redo their Design Control activity from 20 years earlier, to 21 CFR 820.30 standard (and regardless of any post-marketing experience gathered)?

The way I understand it (and I hope I'm not wrong), every foreign manufacturer is required to comply with the applicable FDA General Controls by the time their product is placed on the USA market (for that matter a 510(k) is a notification of intent to commence marketing in 90 days, so let's say this applies from 90 days after initial 510(k) submission, the latest). 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; If retroactive fabrication of records is required, where do you stop? And what about activities covered by part 820, other than Design Controls? Or other FDA General Controls? How far (and wide) does one go back?

To the OP - I find it a bit odd that your 510(k) was cleared without having compliant Design Control documentation, in the first place.
 
M

MIREGMGR

#10
What if a device was developed by a non-USA manufacturer and marketed outside the USA, then 20 years later the manufacturer wishes to place it on the US market, submits a 510(k) and gets a SE letter - would you still say they have to redo their Design Control activity from 20 years earlier, to 21 CFR 820.30 standard (and regardless of any post-marketing experience gathered)?
I didn't say that. I said:

You must demonstrate conformance with the rules that were applicable when the device was approved for marketing.
Which is substantially what you said:

...every foreign manufacturer is required to comply with the applicable FDA General Controls by the time their product is placed on the USA market
 
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