FDA vs NB Fees?

Watchcat

Trusted Information Resource
#1
I'm interested in hearing from those of you who have put the same medical device on both the US and EU markets within a reasonably short period of time, e.g., < 2 years, without using MDSAP.

How did the actual regulatory costs (e.g., FDA registration fee and filing fee, versus NB fees) compare? Was one noticeably more expensive than the other, or were they about the same? If so, which one was noticeably more expensive?

If you reply below, please include 1) the device class in the two jurisdictions, 2) the FDA pathway, 3) the EU Directive or Regulation, 4) approximate timeframe (eg, in the last 5 years vs, early 2000s), and whether this was a startup situation (e.g., new FDA establishment registration, new NB) or an add-on for an established company.

I do not need, or especially want, to know the company, the device, or other such touchy details.

Alternatively, feel free to message me or email me directly:
julie(at)class3devices(dot)com

Thanks in advance! If I get enough replies to learn something, I will share what I learned, as always.
 
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Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#2
Both submitted Summer 2020 (same device review for both)
FDA 510(k) Class II and CE MDD Class IIa
FDA took 6 months
MDD took almost 12 months

Our FDA costs (Used a consultant team) were higher but direct FDA costs were lower
Our CE MDD costs for our NB were about 1/5th the FDA Consultant costs.

MDD review was more frustrating as the review team changed mid-review and new questions were brought up after 8 months which angered me. My perception is because the NB for MDD approval used consultants the approval was more lengthy.
 

Watchcat

Trusted Information Resource
#3
Well, now you've raised some other interesting questions, which I will have to put on my to do list.

Right now, I'm trying to establish a baseline, which is the absolute minimum you must pay (which isn't the same as "spend") to get a device on either market. In the US, you must pay a registration and listing fee; in the EU, if you need an NB, you must have one and you must pay their fee.

Many devices get on both markets without benefit of regulatory expertise, internally or externally. It can be a tortuous experience for an inexperienced company, but CDRH has always been dedicated to providing as much guidance and assistance to small companies as possible. In experienced companies, Engineering can often handle it, if it's a simple "me-too" device. They just use FDA's guidance, the predicate and any applicable technical standards as their guide. Often the predicate is the company's device, so piece of cake.

So, to clarify, how did the NB's fee to review your tech file to support issuance of a CE certificate for your device compare to FDA's filing fee, which helps pay for its review of your submission to support issuance of a clearance/approval/whatever letter?
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#4
FDA was a flat fee IIRC. Our NB was ~ 8X as much.

A little backstory - we could have done both internally however a partner of ours in pharma wanted a pre-sub meeting with FDA. Generally, I try to avoid the FDA as much as possible but we had a pre-sub meeting with the FDA at our partner's insistence. After the meeting, FDA demanded we must update our submission. Given the partner caused this to happen, they agreed to pay half the cost of a 510(k) and we needed it ASAP so a consultant was brought in to help.
 
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Watchcat

Trusted Information Resource
#5
This is the appeal of capturing the most basic costs...they are resistant to being influenced by the wide range of devices and backstories that characterize the industry. The downside is that they consequently provide very limited information to anyone interested in, for example, deciding whether to pursue a CE Mark versus FDA whatever. But they are, as they say, a start.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#6
The manner NBs charge for reviews has a conflict of interest within it imo.

The fee for a substantial change is probably about $3-5K The actual cost of the change for the end result is probably 5-10 X that fee.

The conflict I see is that as long as the NB can think of questions they can invoice the customer. This seems prone to corruption.
 

Watchcat

Trusted Information Resource
#7
The manner NBs charge for reviews has a conflict of interest within it.
There will always be conflicts of interest, I'm afraid. The biggest conflict of interest is that companies pay NBs to certify their devices.
This leave NBs loathe to decline to certify a medical device, because that is likely send the manufacturer to another NB. The more devices the manufacturers have that need certifying, the less an NB is going to want them to go elsewhere, so fortune favors the big. With fewer NBs to choose from now, this situation should improve considerably, but it will always be there.

On the FDA side, the conflict of interest is the same, with user fees, just watered down. And again, it favors the large companies, who have both access and resources to participate in the secret MDUFA negotiations. All companies must pay user fees, not all companies are privy to what goes on behind those closed doors.

The conflict of interest is also there for asking questions, again, just watered down. It doesn't increase revenues (although I'm sure there are those at FDA who would like to work that one out somehow, LOL), but it does promote job security.
 

Raisin picker

Involved In Discussions
#8
There will always be conflicts of interest, I'm afraid.
The current situation in EU is quite complex. As of yesterday, 20 of about 40 NBs are fully functional, the others can only monitor their existing MDD certificates. Those 20 MDR approved NBs could charge as much as they like, since the manufacturers are hard pressed to find another NB. On the other hand, they would not want to bancrupt the manufacturer, and they can easily broaden the customer base, and just accept a few more manufacturers that are looking for a NB. I think that would be the better strategy for the NB in the long run, and fits with my limited experience.
And, the NBs must provide their prices on the homepage now, so you could at least compare standard fees and hourly rates.
 
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