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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?”
Burrell (Bo) Clawson
Robert J Bard
Robert J Bard
Robert J Bard
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
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.
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