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Completing Design Controls after 510(k) Clearance

KMac

Registered
#1
I understand that the concept of requiring Design Controls to complete a 510(k) summary seems like common sense, and generally good practice. However, I'm interested in the legality of these companies that we all hear about, that have managed to get a 510(k) cleared without properly documenting their Design Controls.

Say they were to receive clearance, but held off from selling any devices until they have finished off documenting proper Design Controls in their design history file. If the product was then placed in the market after this documentation was completed, and the FDA were to then audit them, would they get pinged for this disparity in the timelines? For example, if the 510(k) was cleared in May and the final Design Controls in the DHF were signed off in July?

Generally curious, but also, my company is really pushing to do exactly that with each project to expedite timelines and it makes me nervous.

Thanks
 
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Watchcat

Trusted Information Resource
#2
Sorry to say it, but...

As best I can tell...and I have been paying attention...CDRH is oblivious to design controls done after the fact. Actually, it is pretty much oblivious to design controls, except to confirm that they are in place whenever it finally bestirs itself do an inspection, which, in the US, may be 3, 5, 7+ years, after clearance.

The only reason to do design controls premarket is because you value what they contribute to the design process. But that was really always the only reason, IMO. Herein lies the difference between Quality and compliance, which, as someone observed here on Elsmar years ago, hijacked Quality a long time ago. (A long time ago back then, so now a long, long time ago, I guess.)

_____________________________________
CDRH has been talking a lot about “modernizing” lately, but it cannot seem to modernize itself....The Design Controls regulations were passed in 1996, 22 years ago and counting. It is way, way past time for ODE to start acting like it ever even read them, much less understood them, much less did a thing to implement them.
From comments on the De novo Proposed Rule submitted to regulations.gov
by the Regulatory Watchcat,
March 17, 2019
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
CDRH has been talking a lot about “modernizing” lately, but it cannot seem to modernize itself....The Design Controls regulations were passed in 1996, 22 years ago and counting. It is way, way past time for ODE to start acting like it ever even read them, much less understood them, much less did a thing to implement them.
From comments on the De novo Proposed Rule submitted to regulations.gov
by the Regulatory Watchcat,
March 17, 2019
I agree that Design Control regulations (820.30) could do with a facelift, in that they're not detailed enough and a little ambiguous at times, but in essence I think that the're not a lot wrong with them (as written) and that they're not that different from, for example, ISO 13485:2016 s. 7.3 (supposedly "the state of the art"?).
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Say they were to receive clearance, but held off from selling any devices until they have finished off documenting proper Design Controls in their design history file.
As far as I understand that's exactly how it's intended to work. No sales without full design control compliance. I think that the FDA CDRH never intended to review the full extent of design control outputs (which is not the same as design outputs) as part of the 510(k) review, and doesn't really need all of it for making a SE determination. The occasion where the FDA CDRH may indeed be interested in reviewing (sampling) the full extent of design control is the on-site inspection, which, as mentioned, may take place years later. The fact that the system is set up this way implies (to me) that, at least de-facto, CDRH is fine with that.
 

Watchcat

Trusted Information Resource
#5
in essence I think that the're not a lot wrong with them
I think the Design Control regulations are fine, just unenforceable as written, because FDA was never going to keep a device off the market just because design controls were not followed in its development, and, by the time the device is submitted for premarket review, there is no way to fix that without a time machine. So CDRH seems to have largely ignored them, probably because it mostly reviews 510(k)s.

So, with 510(k)s, the situation seems to be that, once you have something cleared, you can make pretty much whatever you want (shades of PIP). Whenever OC shows up, it will look at what you are making now, and confirm that you are controlling your current design, but it will not attempt traceability from what you are making now to what ODE originally cleared, which is to say, whether what you are making now is supported by the data you submitted for clearance and on which ODE's determination was based.

It does premarket approval inspections for PMAs, but whether it connects the dots there, I can't say.

PS I'm not sure why you are following my lead on "CDRH" instead of "FDA," but I like it. I fear now you will be sorry you encouraged me, since I've gotten even more specific, with my references to OC (inspections) and ODE (premarket review), but I'm not just being precise here. The two functions have always been carefully isolated from each other, which may explain some of this disconnect. The "new" CDRH organization puts them together, sort of, so maybe it will help. Can't say I'm optimistic though, because, regrettably, I'm doubtful that CDRH knows enough about medical device design, development, manufacturing, or pretty much anything else, to figure it out, even if they are sharing the same desk.
 
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Ronen E

Problem Solver
Staff member
Moderator
#6
I think the Design Control regulations are fine, just unenforceable as written, because FDA was never going to keep a device off the market just because design controls were not followed in its development, ...
I wouldn't say "unenforceable", just "not enforced". I don't see a regulatory (legal) issue preventing the FDA from showing up for inspection 3 years after a device has been cleared, and at finding out that design controls were not properly implemented for that device instructing to stop that device from further sales, until further notice. (But then, I'm not a legal practitioner...) If this is not happening I assume it is due to some decision the FDA has made or otherwise due to its internal workings; not because of something in the regulation itself.
there is no way to fix that without a time machine.
If that was the case, I'd have had several clients less... (No, I don't have a time machine.) I agree that generating design controls outputs retroactively is "bad" and generally goes against their intent, but it's not impossible, and in some cases it even carries some real value going forward (other than just having the records).
Whenever OC shows up, it will look at what you are making now, and confirm that you are controlling your current design, but it will not attempt traceability from what you are making now to what ODE originally cleared, ...
I can't dispute your statement that that's what they do, but to me it makes little sense, and it's definitely not something that's dictated by the regulations. In the FDA inspections I've attended (not many), the investigators were more thorough than the way you describe it.
which is to say, whether what you are making now is supported by the data you submitted for clearance and on which ODE's determination was based.
I wouldn't expect OC to go as far as determining whether the current design is supported by the original submission's data (I don't expect that to be within their expertise), but I'd definitely expect them to verify that there is an unbroken design control trail from the original (510k-cleared) design to the one currently being manufactured. That should cover most PIP shades.
PS I'm not sure why you are following my lead on "CDRH" instead of "FDA," but I like it.
The FDA is quite vast; the sections that deal with food, drugs and tobacco products, for example, have nothing to do with devices' design controls, so I though why not CDRH. I might still go back to "the FDA" occasionally... :)
 
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Watchcat

Trusted Information Resource
#7
not because of something in the regulation itself

No, not in the regulation itself, just a lack of political will. Things would get very ugly for FDA, if it tried to keep a device off the market when its review determined it was otherwise marketable. All those millions of patients out there, dying like flies for lack of another "life-saving, breakthrough" me too. And all those lawyers lined up to file suit.

But since it doesn't review the design control outputs during premarket review, it wouldn't find out until the device was already on the market, and it's very difficult for FDA to pull a device from the market. There are some legal reasons for that (weak enforcement authority), but a lot of that would be political too.

in some case it even carries some real value going forward

That doesn't make up for all the value lost, IMO.

I can't dispute your statement that that's what they do

I can, due to lack of evidence, which is why I say things "as best I can tell" and "the situation seems to be."

In the FDA inspections I've attended (not many), the investigators were more thorough than the way you describe it.

That's good to know, but it's not that I don't think they are thorough (I think some are, some aren't, just like NB and ISO auditors). I just don't think they connect those dots. I don't think they know they are supposed to be connected.

I'd definitely expect them to verify that there is an unbroken design control trail from the original (510k-cleared) design to the one currently being manufactured.

Did you see them do this in any of the inspections in which you participated?
 

Ronen E

Problem Solver
Staff member
Moderator
#8
it's very difficult for FDA to pull a device from the market. There are some legal reasons for that (weak enforcement authority), but a lot of that would be political too.
(Emphasis added)
I wasn't ware of that.
That doesn't make up for all the value lost, IMO.
Okay, I get it now. By "fix" you meant restore to an ideal state (which is hardly ever achieved even when design controls are applied upfront, but never mind), while I was referring to a we-don't-live-in-an-ideal-world, reasonably acceptable state (admittedly, compromised).
I just don't think they connect those dots. I don't think they know they are supposed to be connected.
Seriously?... I thought it would go without saying. Otherwise, it's not really design control.
Did you see them do this in any of the inspections in which you participated?
Yes, but I must admit it was over a decade ago.
 

Watchcat

Trusted Information Resource
#9
I wasn't aware of that.
However, what it can do is crush sales, by issuing warning letters, requiring black box warnings, etc., until the company takes it off the market itself. But it can't pull that off politically unless there are dead or seriously injured patients. Mere violation of some obscure regulations the public can't understand is a non-starter.

Seriously?... I thought it would go without saying. Otherwise, it's not really design control.
Exactly.

Yes, but I must admit it was over a decade ago.
Well, there are those who would say that CDRH isn't what it used to be, but I'm not sure that isn't just nostalgia talking, coupled with those who say it having been younger and possibly less wise back in the good old days.
 
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Watchcat

Trusted Information Resource
#10
So I have another question, which comes from a framework of design control as a process, rather than a set of documents.

If you are going to try to "do" design control after the fact, then how does that work, given that the whole process starts with determining user requirements?

If you didn't assess user requirements at the outset, and instead do so after the fact, what do you do if it turns out that your design does not meet user requirements? Or do you just look at the finished design and document that its features are what users require, even though you've never determined that this is the case?
 
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