8 min reading time

A group member asks, “Does anyone have a ballpark figure in cost and timeline estimates for a third party to audit, assess, file and complete a class II 501(k) submission?”

---

Steven Ziemba
Exec. V.P. Quality, CLinical & Regulatory Affairs at Altaviz, LLC
For a 510k with several predicate devices and for which no clinical study is required, I would charge between $5-10K. However, that assumes the firm has their act together in Design COntrol/Documentation and either knows what kind of preclinical phys/chem/bio/sterility testing is required or already has it done. Frequently, I find they neither know what tests to do nor how to get them done. If they want me to determine the testing needs, the charge could go to $15+K. I generally encourage them to get their own samples to the lab and schedule the testing on their (its cheaper for them to do that instead of paying me), but frequently they just want to turn the whole thing over to me to do. Then, charges are based on time and materials. Same thing if I need to get involved in design control.

David Lim
FDA Consultant Speaker | Drugs, Biologics, Medical Devices & IVDs, Combination Products, 483s, & FDA Inspection
Also it is imperative that a device development is planned ahead with some reasonable level of awareness for regulatory requirements in US, Health Canada, EU, etc. as going global becomes customary or rather natural. As for technical aspects, it is recommended to begin to use “recognized standards” early in the process (e.g., design input requirements) – [Quality by design (inherent safety by design) -> Implement protective features -> Manuals, warnings, cautions, precautions, contraindications,etc. -> All risks controlled/mitigated].

Robert Odell
Chief Operating Officer (COO) at Cardiac Insight, Inc.
One key to controlling the 510(k) cost and time is to make certain the development process is well controlled and properly documented. Holes show up at the time of the submission. Ideally, you would work with your 510(k) person throughout the development to “fill in the blanks”. It makes the final work MUCH easier.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
If the FDA asks you to do additional work and resubmit and then add more data and then do another use compliance study, all initial bets on time costs go out the window.

John Minarovich
Field Account Executive – West Coast at D-Link
It might be a good idea to question the need for regulation of your project and look for ways to mitigate those costs. The Tenzing Group might be a good place to start. [http://www.tenzinggroup.com/|leo://plh/http%3A*3*3www%2Etenzinggroup%2Ecom*3/zhAy?_t=tracking_disc]

David Lim
FDA Consultant Speaker | Drugs, Biologics, Medical Devices & IVDs, Combination Products, 483s, & FDA Inspection
For tough/complex 510(k) cases, please consider us (REGULATORY DOCTOR) at [http://www.RegulatoryDoctor.com|leo://plh/http%3A*3*3www%2ERegulatoryDoctor%2Ecom/chsH?_t=tracking_disc]

Doug Daniels
CEO at Stroma Medical Corporation
I would like to agree with Jon McIntyre’s comment about using Joe Curtis. He is one of the most user friendly RA/QA people that I have worked with and he gets the job done correctly the first time.

Alan Morgan
Sales Engineer at Diablo Sales and Marketing
We commonly assist companies in developing products and taking them through the 510K process. Taking into consideration regulatory, aging, and packaging on top of the development this can run somewhere about 18 – 24 months and cost anywhere from $400,000 $800,000. Pricing and timing can depend on the complexity of the device, how well it’s defined as well as level of support coming from the developing company.

Jon McIntyre
Medical Device Product Development Expert|Outsourced Solutions in Medical Device Engineering and Manufacturing
If you want to speak to someone live about the estimates you are looking for, you could call Joe Curtis at Bridgemedica. He is the VP of RA/QA here and expert in providing the services that you mention. His direct line is: 508-406-2101

David Lim
FDA Consultant Speaker | Drugs, Biologics, Medical Devices & IVDs, Combination Products, 483s, & FDA Inspection
“Do it right the first time” is indeed one of the best ways to save time, energy, and resources, if not the best although I would argue it is the best way under most of the situated circumstances.

Doug Daniels
CEO at Stroma Medical Corporation
I agree with Sam about leaving regulatory submissions to the pro’s to get it done correctly. Speaking as a CEO in several companies over the past 13 years, the time, and therefore the money to try and do this process on your own is not practical, with a high chance to not include necessary data and in the long run is not very cost effective. Do it right the first time because the biggest expense in any project is the cost of failure. The cost to get the final approval is not in the filing or submission fees but, in all of the costs to insure your design testing, sterility testing, product verification and validation for the submission are all done correctly. That is where you meter is really running

Sam Kenton
Sales and Client Relations Executive at Boston Engineering
510(k) costs are difficult to estimate without more detail on it being a traditional, special or abbreviated 510(k). Using a third party that is skilled in this area is worth every penny. We recently completed one for a client, an although the costs upfront may seem high, the savings of doing it the correct and documented way are priceless. It can be a difficult process to comprehend. Ask yourself how much does a recall cost? How much is your time worth working on items that you excel in? Let the pros take care of it. Would you want a barber doing your hip replacement or a hip surgeon? This is why I enjoy the engineering outsource services business. Once clients see the work and results they are glad that their time and resources were put to better use.

Robert J Bard
Vice President Clinical Development at Hygieia Research LLC
David, Agreed.

David Lim
FDA Consultant Speaker | Drugs, Biologics, Medical Devices & IVDs, Combination Products, 483s, & FDA Inspection
Robert, in fact, a fair price would have been around $50K for the said project.

Robert J Bard
Vice President Clinical Development at Hygieia Research LLC
David, too expensive can be a common utterance when quoting for a project but fairly unusual for something”desperately needed” and incident to a “Class I recall”. Glad they were your client.

David Lim
FDA Consultant Speaker | Drugs, Biologics, Medical Devices & IVDs, Combination Products, 483s, & FDA Inspection
Mrs. Bard and Packard, your comments on prices are both reasonable under the situated circumstances depending upon the clients. In fact, I prepare 510(k)s almost in no time. I frequently give LIVE web seminars on 510(k)s and developed 510(k) templates. I also provide LIVE web trainings on 510(k) and PMA drafting. FYI: for one case, I was working on a 510(k) for a company with over 10 billions of profits annually. When I said, their 510(k) would be around $10-$20K. They said that it is too expensive. They even had a class I recall and the device wasn’t cleared by the FDA. They desperately needed to submit a 510(k) asap. This was a good experience.

Rob Packard
510(k), CE Marking & Quality System Consultant
Just to clarify, I am almost certain that the 4-6 weeks time period that Mark mentioned matches up with the $25-30K range. This works out to a min. rate of $105/hour and $187.50/hour maximum (assuming a 40-hour week). I have no idea what Mark’s hourly rate is, but $150-$250/hour is typical for regulatory consultants. A $100K project is more likely to take 3-4x as long as a typical project (i.e. – 12-16 weeks). I also suspect that there are periods of time in a larger project where no work is being done by a consultant, because they are waiting for documents.

Robert J Bard
Vice President Clinical Development at Hygieia Research LLC
Robert, I believe what you have outlined is in keeping with what I have said previous. I am basing my opinion on current submissions and hundreds of 510(k)s that I have prepared. Also note, the number Joe was asking for was the cost and timeline for a third party (consultant). I can’t completely agree with some of the costs though…$100,000 for a consultant to prepare and submit a 510(k) requiring 240 hr (6 wk) is $416/hr. I would be happy to quote on this type of assignment.

Rob Packard
510(k), CE Marking & Quality System Consultant
Mark DuVal answered this question during 10x. The number range he provided was $10K – $100K, but he indicated that many range between $25-30K. Mark is an expert specializing in FDA submissions. His practice has served 500+ clients over the years and the volume provides a better perspective. $10K is hard to achieve, because companies seldom have all the documentation submission ready. $100K is rare, but it doesn’t include the costs of verification, validation or any clinical studies that may be required (10-15% of 510(k) submissions now require clinical data). De Novo applications would also increase the complexity.

Probably the more important metric to evaluate is what the mean-time to receiving a clearance letter is and how may weeks it took to prepare the submission. If the company documentation is “submission ready”, then 4-6 weeks is possible for preparation of a submission. If documents are not ready, then the person preparing the submission is waiting. Mean times to receiving a clearance letter from the FDA vary widely from product code to product code. I would review the summary details for submissions by competitors in order to develop an estimate of this.

I know one person that recently received a clearance letter in 40 days. I think the norm is 100-120 days, if the submission is complete and well-organized. A Special 510(k) would be even shorter. Historically 15-20 days is possible for a Special, but 30-45 days is more of the norm. These numbers are skewed by companies that attempt to submit a Special for a change that represents a Traditional submission.

Robert J Bard
Vice President Clinical Development at Hygieia Research LLC
Gary, your number of are interesting and probably very specific to a type of IVD but they are very different from the IVDs I have worked and I am currently working. Possibly you are quoting for a PMA or a Class III (EU) or Class IV (Canadian) submission.

In my first posting to the question of costs, I was trying to give Joe an idea of what I am see currently for traditional 510(k) submissions and as the question was posted, it was not specific to IVDs. The cost of a traditional 510(k) does not normally require/include “clinical” testing. $500/patient and 200 patient does not appear to be in line with the Joe’s question for a traditional Class II Medical Device.

Joe’s question was posed as what is a “ballpark figure in cost and timeline estimates for a third party to audit, assess, file and complete a class II 501(k) submission”. The estimates of time were to review the sponsors documentation, suggest any required testing not already completed, possibly assist in Risk Management preparation as needed and so on. The sponsor has to conduct V/V for devices (820.30 requirements), animal testing, biocompatibility testing as needed, sterilization validation, packaging validation, and others as needed. Additionally for traditional medical devices and some IVDs Human Factors testing will be necessary (but this has not been requested in all cases for premarket notifications).

Returning to your $500/patient, this seems a little on the high side. Because an uncleared IVDs can’t be used without a cleared device in a clinical trial (IDE) the actual cost should be fairly low or only a handling cost (depending on who is doing the actual diagnostic test/assay). In the last 10 IVD 510(k) I have submitted, there was no cost for the test sample. Assuming your comment was not directed at a PMA submission, the number of subject samples we have been including in our 510(k)s has been a low of 30 to a high of 424 (the numbers vary on availability, more because there was no charge for them and the sponsor conducted all testing).

You cite viral testing as a cost to submit a 510(k)…this is not something that every 510(k) requires and to date, I have only had to do viral testing on BLA cell therapy products.

Back to Joe’s original question, as David and I both said, the cost for a third party to prepare and submit a traditional 510(k) has a pretty good range. For a company trying to budget for regulatory support, they need to look to an explanation of the complexity of the submission…a simple submission should cost around $6-9,000 and a more standard device should run somewhere in the $15-30,000 and a complex device like an infusion pump (with all of the testing and submission requirements) is likely to be north of $30,000. None of the third party costs include any internal or external testing or validations costs that are required for the submission nor does the submission include any human factors work and any clinical testing/patients costs.