I initially found it incredible that you found this incredible, but then I looked at your LI profile and saw that you have clinical roots. Also, maybe by "small company" you mean an actual small device company, not a startup. They do exist, but in the device industry, the term is widely used as a euphemism for a startup, ashamed to call themselves by their own names, I think.
I have yet to hear a device RA consultant report having found a device startup with anything remotely approximating a legitimate QMS. Since many of them aren't in need of one, and may never need one, that's not a surprise. Unfortunately, often not too much better to be said about their tech file, which they desperately do need.
As for the whales, if they haven't had a top-notch QMS for decades now, they simply don't want one. If they want one, they have plenty of in-house QMS professionals who are more than competent in this area, so I was initially puzzled as to why they would want someone from outside to assess, particularly someone who doesn't specialize in QMS. I think maybe you aren't looking at the actual whale, just a little fish in its belly, one it hasn't yet decided whether to digest or not, so "as long as you are there," may as well have you take a look, is what I'm thinking.
As for not talking to the FDA because it costs more money, I am happy to see device companies spend more money. The question is whether or not it is being well spent, and you can't know that unless you know what their business objectives are, which they are not always inclined to share. There are those in the device industry (or swimming around it) who clearly think FDA should serve as a free-of-charge regulatory consultant. And product development consultant, too. I am perfectly happy to see them get what they wish for, and to have to pay for it, too.
"we've pushed things all the way to the Commissioner's office" Sounds very Minnesota to me. Maybe even a particular club that seems to meet regularly up there. If the pandemic ever disappears in a puff of smoke, you might want to consider spending some time in a different tidepool. Not that you particularly need to, but because I think you would find the view very different, and that you would find this difference very interesting. A lot of people don't especially want to know.
So, I just HAVE to ask...what percent of 510(k)s do you think require clinical data these days?
Anyway, glad you are enjoying the work. I love the work too. It's the only reason to be in, or even near, this mess, IMO.
------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 08-Sep-2020 04:14
From: Joy Frestedt
Subject: 510k writing costs
Hi Julie,
We often find small companies do not have a quality management system (QMS) and they just want a quick, low cost 510(k) as a "me too" process without having much for infrastructure. As we do a lot of these, we see all kinds of incredible things, even at HUGE companies. Hard to believe, I konw, but we've seen global giants without a 510(k) "standard" process developed at all (they just try to gather the data when they need it - takes a lot longer, costs a lot more and is quite poor quality due to the lack of quality oversignt).
I've learned never to assume a company knows and understands 21CFR820 (Medical Device Quality System Regulations). These are the types of things which I find make the costs become much higher.because we are asked to cover so many details which are simply out of scope for writing up and submitting a 510(k).
Also, yes, to whomever asked if the prices were really so variable. I'd say $15,000.00 - $250,000.00 would be a good starting point for "low cost" price discussions for a 510(k) - what do others think of this range? The low end is more for a really easy "Special" 510(k) and the high end is more likely a 510(k) with clinical data or multiple bits of FDA feedback included (though the price can be much higher if the clinical data or the regulatory negotiations are complicated - we've pushed things all the way to the Commissioner's office and this takes time and is quite costly).
In addition, sometimes people think you should talk to the FDA about everything - this contributes to costing more money too (at least this is my experience since you have to track and address all the details from all of those Q-subs even though they are "non-binding"). This really is fun work, lots and lots of details... I love it and hope you all do too!
Cheers,
Joy Frestedt
------------------------------
Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Incorporated
Saint Louis Park MN
United States
612-219-9982
jf@frestedt.com
Original Message:
Sent: 08-Sep-2020 02:15
From: Julie Omohundro
Subject: 510k writing costs
Why the QMS?
------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 03-Sep-2020 09:50
From: Joy Frestedt
Subject: 510k writing costs
In this our experience at Frestedt Inc, we usually start with reviewing the document management system, the quality management system and in particular the regulatory plan to ensure the 510(k) is the correct path [not PMA, de novo or no 510(k) required- yes, we have seen all of these in our responses to questions like this one.] Next, we typically verify the predicate is appropriate (one device, same indication, same bench testing profile, etc.) Then we check to see if human clinical trial data are needed (used to be only about 10-20% 510(k) devices needed clinical data but this is increasing, esp. due to European MDR CER requirements). I agree with others, you will want a person or group to help guide you.
Joy Frestedt, PhD, CPI, RAC, FRAPS, FACRP
President and CEO
Frestedt Inc.
Jf@frestedt.com
952-426-1847
Sent from my iPhone
Original Message:
Sent: 9/2/2020 5:48:00 AM
From: Anonymous Member
Subject: 510k writing costs
This message was posted by a user wishing to remain anonymous
Hi all,
can somebody provide an idea of costs (or ranges of cost) for third party 510k writing?
Any tips on how to find/identify a good consultant/writer? Are there consulting firms or freelancers that have a well recognized track record in this space?
Also, I wonder how this type of activity works, i.e., whether the consultant double check the project at the beginning to make sure that all the activities that are needed for the 510k composition are covered or he/she does that at the end when testing is performed and the documentation is already produced. In this last case, I assume sometimes there may be bad surprises.
It would be great if you could share your experience.
Thanks