How to deal with FDA after not reporting anything for several years

MDD_QNA

Involved In Discussions
#1
I've started at a new company and just recently found out that nothing has been done correctly here. What surprises me is how they get to continue with the work they are doing... Anyways, they are developing the product and want to file a 510(k) for one product family and then another 510(k) for another product. However, despite significant changes to the products they have not filed any 510(k)s since 2011 since they have just ignored the regulatory part and/or hired people that couldn't withstand the pressure from higher management.
Anyways, so filing this 510(k) I have told them that we need to report the changes done since the last predicate device. What are your take on this and how should I go about it? What do I tell FDA about them not reporting anything between 2011-2019? Is there another way?
The product is a class IIb medical device with software.
 
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Ronen E

Problem Solver
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Moderator
#2
Risky situation.
Someone needs to come clean, and I reckon you should have nothing to do with it. If top management is not backing you up on this very clearly, I would seriously consider starting to look for another job.
It's quite likely that there will be consequences to coming clean because apparently they broke the law, and you should be sufficiently confident you are not going to end up as a scapegoat.

Sorry I can't be more positive.

Edit: From my experience, when a company doesn't give much of a $h!t about regulations for such a long time, it's hardly likely to change just because a white knight just rode in and is determined to turn it around.
 

shimonv

Trusted Information Resource
#3
As Ronen implied, the biggest challenge you are facing is company culture, not FDA.

From the looks of it it, your submission (I assume traditional) should include the new features as well as "Catch-up". You need to blend/merge them together so as not to raise concerns, without dates. This is a regulatory writing challenge, but it has to be done.

Also, obviously, you need to fix the engineering change process so it includes regulatory assessment.

Shimon
 

Ronen E

Problem Solver
Staff member
Moderator
#4
As Ronen implied, the biggest challenge you are facing is company culture, not FDA.

From the looks of it it, your submission (I assume traditional) should include the new features as well as "Catch-up". You need to blend/merge them together so as not to raise concerns, without dates. This is a regulatory writing challenge, but it has to be done.

Also, obviously, you need to fix the engineering change process so it includes regulatory assessment.

Shimon
Actually, this is quite the opposite of what I intended to say.
I meant literally coming clean with the FDA (and facing the music). What you describe above sounds to me more along the lines of a cover-up.
 

craiglab

Involved In Discussions
#5
I would go through the exercise of formally documenting the changes with respect to FDA guidance on when to submit a 510(k) for a change, and do this cross-functionally and for each change. Answer the questions, document test reports, risk assessments, labeling changes, etc. Then document the meeting(s) where these assessments and conclusions are discussed with top mgmt.

Also take a close look at complaints and see if MDRs were not filed, and I would want to know if any of the changes were to address adverse events.

Also research if there have been any related corrections or removals, in any shape or form.

If the post-market landscape is okay then I would proceed with (simply) submitting a new 510(k) and document the changes within, and I agree with Shimonv to disclose but not to raise concern.

If there has been serious mishandling of post-market matters then you may be facing significant business risk. You may be anyway. But the details should come out of the regulatory assessment and I would strongly advise to get that in order first.
 

Watchcat

Trusted Information Resource
#6
As it turns out, I just happen to know someone who had this experience recently. My colleague advised the company that, if they submitted a a whole lot of stuff at one time, it would trigger an inspection, which it did. I think FDA monitors a lot of these things statistically, rather than by actual content review. So, for example, if a company submits five times as many MDRs reports in a single month as it has submitted in the past five years, that sets off a statistical alarm bell, I think. And once the bell rings...no snooze buttons in a bureaucracy.

So, you could work along at a (hopefully expeditious) pace, submitting some, then submitting some more, then more, until you are all caught up, and maybe not trigger an inspection. On the flip, depending on FDA's track record of inspecting the company, you might get inspected on a routine basis before you get caught up, and that is the worst case scenario....FDA shows up and finds all of these reporting deficiencies, warning letter in your future. Maybe better to just do it and brace yourself for an inspection. At least when you come out of the other side of that, you are finally "clean."

Above all, don't just come "clean," but add a good dose of PA to your CA. I would focus equally on catching up and putting procedures in place that virtually guarantee this never happens again. That's your only hope for ameliorating some FDA's wrath, IMO.
 
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shimonv

Trusted Information Resource
#7
Ronen,
My intention is not to cover-up but to disclose with prudence.
I have been in a worse situation where few MDRs should have been reported and were not, and it was clear that there were some very serious QA issues in the company. The CEO then took a very bold move and initiated a voluntary corrections & and removals. That is rare.

Obviously we don't know mach about what is going on in MDD_QNA's company. He did mentioned that he is new in this company. So my advise is to be careful about going from 0 to 100 (literally coming clean with the FDA) unless the situation really demands it.

Shimon
 
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Watchcat

Trusted Information Resource
#8
What surprises me is how they get to continue with the work they are doing.
Sigh. Then you must be new to this, and might want to get out while you are still young...

What's discouraging is that I don't think we must all be talking about the same sad little company. That possibility did come to mind, but no, there are lots of companies out there just like this.

Is your company located in the US? Do you know when it had its last FDA inspection?
 
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Ronen E

Problem Solver
Staff member
Moderator
#9
Ronen,
My intention is not to cover-up but to disclose with prudence.
I have been in a worse situation where few MDRs should have been reported and were not, and it was clear that there were some very serious QA issues in the company. The CEO then took a very bold move and initiated a voluntary corrections & and removals. That is rare.

Obviously we don't know mach about what is going on in MDD_QNA's company. He did mentioned that he is new in this company. So my advise is to be careful about going from 0 to 100 (literally coming clean with the FDA) unless the situation really demands it.

Shimon
Sure.
He/she just needs to be aware that he/she can't benefit the "newbie" status for a long time, and once he/she starts "participating" (even just by default) in any turn-a-blind-eye conduct he/she will quickly become an accomplice. Different from other places, in the USA the FDA is a law-enforcement agency and such a situation might (worst-case) deteriorate into criminal proceedings. I know I wouldn't take such a risk.
The suggestions above sound really great if one assumes that the org's leadership is all-in for it; but from a more realistic perspective, if that was the case the org would have probably not be in such a situation in the first place. Turning a sick org around is not that easy, and sometimes it's better to be humble and accept that some things are beyond one's powers.
 
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