The FDA 510(k) submission process is complex and can be challenging for companies, especially those unfamiliar with the regulatory requirements. Over the many years we've spent helping device firms gain market clearance through this pathway, we've seen companies realize they need expert help in several areas, including:
Preparing the required 510(k) documentation, which often involves a complex workstream that can be time-consuming and requires a deep understanding of regulatory requirements.
Summarizing test reports.
Developing a regulatory strategy that meets FDA requirements and maximizes the chances of clearance.
Preparing and submitting pre-submission documents, scheduling meetings, responding to requests for additional information, and managing other interactions with the FDA.
The FDA Group's Nick Capman spoke with our firm’s veteran 510(k) consultant, Trey Thorsen, to address some of the most frequently asked questions about navigating the premarket notification process.
Trey is an experienced regulatory affairs consultant who has helped numerous startups and mid-size medical device companies clear their Class I, II, and III devices for the U.S. market.
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Summary, Key Points, and Practical Takeaways
This interview has been edited for clarity and length.
Nick Capman: Trey, could you tell us about your background?
Trey Thorsen: I’ve been in regulatory affairs for about 15-16 years. I started as an analytical chemist, and after working at a small company where I had to wear many hats, I developed a passion for regulatory affairs. I completed my Master’s in Regulatory Affairs at the University of Georgia in 2009. Since then, I’ve worked with both small and large companies, like Riker and St. Jude (now Abbott), and have experience with Class 1, 2, and 3 devices from an FDA standpoint.
If I want to distribute a manufacturer’s product under my own company name, do I need to submit a 510(k)?
No, you don’t need to submit a 510(k). However, your company name should be on the label, stating “distributed by” or “manufactured for.” Also, ensure you have a quality agreement in place with the manufacturer to clarify responsibilities around labeling, design specifications, and handling complaints.
Can foreign companies submit a 510(k)?
Yes, they can. Foreign companies follow the same 510(k) submission requirements, and they must pay the appropriate fee. In 2023, the standard fee was $19,870, and the small business fee was $967. Foreign companies must also have a U.S. agent to handle FDA-related communications and inspections.
Are there any other fees aside from the 510(k) submission fee?
Yes, all manufacturers must register their establishments with the FDA, which involves an annual fee—around $6,000 in 2023. Additionally, foreign manufacturers need a U.S. agent, which can involve variable costs depending on the firm you choose.
Do companies need to register their facility before submitting a 510(k)?
No, companies are required to register within 30 days of distributing the device. However, once you’re registered, you’re open for FDA inspections at any time.
Do you need to provide documentation proving compliance with the quality system in the 510(k) submission?
No, but you do need to follow design controls, supplier controls, and other elements of a quality system. While you don’t need to provide proof during submission, the FDA expects you to have these systems in place.
Does my facility need to be inspected before submitting a 510(k)?
No, but having an inspection—or hiring a consulting firm to audit your quality management system—is a good way to prepare and address potential issues before the FDA does.
What’s the general timeline for a 510(k) submission from start to finish?
The FDA has 90 days to review a traditional 510(k), but if they ask for additional information, that timeline pauses. Companies typically get clearance within three to six months, though it could stretch to eight months, depending on the questions the FDA asks.
Are there any ways to speed up the process?
Yes, there are third-party review facilities approved by the FDA that can expedite the process. Additionally, the special 510(k) program allows for a 30-day review if the device is a modification of an existing device your company already has on the market.
What are some common pitfalls for companies filing a 510(k) for the first time?
Not having all your verification data or biocompatibility testing completed is a major issue. I also recommend submitting a pre-submission (pre-sub) to the FDA to ensure alignment on your testing and predicate strategy.
Is a pre-submission required, and are there fees?
A pre-sub isn’t required, and there are no fees. However, it’s a good idea if you have questions about your testing or predicate strategy, as it can save time and money by getting FDA feedback early on.
What would you say to someone considering doing a 510(k) themselves versus hiring a consultant?
For small companies with limited resources, it’s possible to do it yourself, but highly beneficial to use an experienced consulting firm. There’s a lot of regulatory complexity, and mistakes can delay your clearance.
Are there any differences between a 510(k) for software as a medical device and a standard medical device?
Yes, software as a medical device can involve different risks and considerations, depending on its use. There’s a specific section in the 510(k) for software, but if it’s a standalone software device, you’ll need to address additional factors like cybersecurity.
Any last tips for small businesses entering this process?
Definitely consider using a consulting firm. The 510(k) process can be frustrating if you’re not familiar with it, and having experienced guidance can save you a lot of time and stress.
Read our in-depth 510(k) explainer: FDA 510(k) Explained: A Basic Guide to Premarket Notification
Need 510(k) support? Talk to us
At The FDA Group, we help you move through the 510(k) submission process quickly and efficiently. Our regulatory affairs professionals have extensive experience and knowledge, with some having worked directly with and within the FDA.
We carefully deploy time-tested best practices during each step of the regulatory process, helping you maximize the likelihood of obtaining market clearance without delay. Our deep bench of regulatory experts covers every dimension of expertise required to make the 510(k) clearance a success, no matter where you are in the process.
Each specific 510(k) consulting engagement is tailored precisely to your needs and can include, but is not limited to:
Regulatory strategy development — Assistance with determining the most appropriate regulatory pathway and the preparation of a comprehensive regulatory strategy.
Review and analysis of the device and its predicate — Determining the device's classification and the applicable predicate device(s).
Preparation of 510(k) submissions — Writing and compiling the 510(k) submission.
Interaction with the FDA — Facilitating communication with the FDA, including responding to agency questions and requests for additional information.
Support throughout the review process — Monitoring the review status, providing guidance and support throughout the review process, and managing any necessary post-submission activities.
Post-clearance support — Providing ongoing regulatory support for post-approval changes, periodic reporting, and maintenance of device marketing clearance.
Need expert help planning and executing compliance projects or connecting with a quality and compliance professional? Get in touch with us. If we haven’t worked together yet, watch our explainer video below or head to our company introduction page to see if we could help you execute your projects now or in the future.
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