Posted by Rob Packard on August 3, 2021

How much does a 510k cost is the most common question I receive from customers, and there are three parts to the cost of a 510k.

If you want to save $9,559 on your 510k cost of submission to the FDA, you need to listen to ALL of this video and follow every single step in the process. Most of our clients forget one of the steps and end up paying full price for their 510k.

There are three parts to the 510k cost of submission:

1. Testing
2. Submission Preparation
3. FDA User Fees

Highest cost is testing

The testing cost is the biggest cost, but I think the average is around $100K for our clients. The more you can do in-house, the lower the testing costs will be. Biocompatibility testing for a non-invasive device might be only $13,000, but a long-term implant can cost as much as $100,000 for the implantation studies. Sterilization validation testing depends upon the method of sterilization and whether you are doing a single-lot method or a full validation. Typical costs for EO sterilization validation are around $15,000, and then you should add several thousand more for the shelf-life testing.

For devices that are powered and/or have software, you will need to perform software validation in accordance with IEC 62304 ed 1.1 (2015). There are also five FDA guidance documents that apply:

1. General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 2002)
2. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)
3. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices (September 2019)
4. Guidance for Industry and Food and Drug Administration Staff Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2014)
5. Guidance for Industry, FDA Reviewers and Compliance on Postmarket Management of Cybersecurity in Medical Devices (December 2016)

You can do all of the software validation in-house, but some firms choose to outsource the validation of software. In the long-term you need to learn this, and it pays to hire an expert in IEC 62304 to help your team learn how to document software validation if you have not done this before. Typically, software validation documentation will be between 300 and 1,000 pages in length.

Electrical safety and EMC testing are often the most expensive part of the testing process for our customers. EMC testing should always be done first to make sure that you can pass the immunity and emissions testing. If you have to modify the device to pass the EMC testing, then you will need to repeat any electrical safety testing. The total cost of this testing is typically $50-60K.

Performance testing is the last part of the testing process. Performance testing should be performed on sterile and aged products if your product requires sterility and you are claiming a shelf-life. Most of the testing is benchtop testing only to demonstrate performance. This includes simulated use testing (e.g. summative usability testing), cadaver testing, and computer modeling. Benchtop performance testing is typically tens of thousands of dollars to complete, but you might be able to do the testing in-house. If animal testing is required, this typically costs around $100K. Finally, if a human clinical study is required (i.e. ~10% of 510k submissions). Then you should expect to spend between $250K and $2.5 million. Some simple clinical studies (e.g. IR thermometers) cost less than $100K, but these resemble benchtop performance testing in many ways.

Second highest cost is the cost of submission preparation

Medical Device Academy has two different options for preparation consulting fees. Your first option is hourly consulting fees. The second option is a flat fee. In August 2021, we are charging $3,500 for pre-submission preparation and $13,100 for 510(k) submission preparation. Therefore, the total cost is $16,600 if you need to request a pre-submission meeting.

510k cost #3 is the cost of the FDA user fee

You have three options for your FDA user fees. The first option is to avoid the FDA altogether and submit to a third-party reviewer. We only recommend one third-party reviewer, because the other companies do not have sufficient experience to have predictable review times and positive outcomes. The quote we received recently was $13,600. If you submit directly to the FDA, the standard user fee is $12,745. If you apply for small business status, and the FDA grants you that status for the fiscal year you are submitting, then the user fee is $3,186.

Reduce 510k cost by applying for small business status

Every medical device company that has revenues of less than $100 million annually can apply, but you must apply each year. There is no application fee, but you need to complete FDA Form 3602 if you are a US firm. The form must be completed for each subsidiary too. FDA Form 3602A must be completed for foreign firms, and the national tax authority must verify the accuracy of your income statement on the form in order to submit to the FDA. If your national tax authority refuses to sign the form you can provide a justification, but I don’t know anyone that has successfully done this yet. The qualification review by the FDA requires 60 days. Therefore, you should apply every year in August for the next fiscal year (October 1, 2021 – September 30, 2022 is FY 2022). The form will request that you include your Organization ID #. A Dun & Bradstreet Number (DUNS #) is also required if your firm is located outside the USA. Finally, you need to attach a copy of your tax return. Therefore, you must file your tax return–even if your firm had a loss or had no revenues. You can also take advantage of R&D tax credits in the USA or Canada if you are a start-up device company developing a new device.

About the Author

Rob Packard is a regulatory consultant with 25+ years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.

Source: https://medicaldeviceacademy.com/510k-cost/