FDA 510(k) Submission Tips for Medical Device Developers

To launch a medical device in the US, developers must gain FDA permission. For most Class II devices, this involves submitting a 510(k) premarket notification to show the product is safe, effective, and substantially equivalent to an existing device. But with over 75% of first-time submissions rejected, what are the common pitfalls — and how can you get FDA 510(k) clearance  right the first time?

What is a 510(k) submission?

510(k) is a pre-market submission of documentation that you can make to the FDA to demonstrate that your Class 2 device is safe and effective and similar to other approved products on the market. It is named after section K of the Food, Drug and Cosmetic Act, which requires medical device manufacturers to tell the FDA they intend to market a medical device at least 90 days in advance of launch. But be warned, you can’t legally launch or sell your product in the US unless and until you have that 510 (k) permission from the FDA.

Who can make a 510(k) submission?

You can submit a 510(k) if your device is classified as Class II, which is typically a medium-risk device. To gain approval, you must show the device is ‘substantially equivalent’ (SE) to a predicate device that’s already on the market. Unlike Class III devices, which require Premarket Approval (PMA), Class II devices can get quicker and less costly approval through the 510(k) process.

The key is proving that your device has the same intended use and meets the same safety and effectiveness standards as the predicate device. If it’s a new, high-risk device, you will need to go through a more extensive PMA process, which includes clinical trials and significant scientific evidence.

What are the required contents of the 510 (k) submission?

The 510(k) may be less time consuming than a PMA, but it’s not an easy submission to make. Here’s the list of required contents drawn from the FDA site:

1. Medical Device User Fee Cover Sheet (Form FDA 3601)
2. Center for Devices and Radiological Health (CDRH) Premarket Review Submission Cover Sheet (Form FDA 3514)
3. 510(k) Cover Letter
4. Indications for Use Statement (Form FDA 3881)
5. 510(k) Summary or 510(k) Statement
6. Truthful and Accuracy Statement
7. Financial Certification or Disclosure Statement
8. Declarations of Conformity and Summary Reports
9. Device Description
10. Executive Summary/Predicate Comparison
11. Substantial Equivalence Discussion
12. Proposed Labelling
13. Sterilisation and Shelf Life
14. Biocompatibility
15. Software
16. Electromagnetic Compatibility and Electrical Safety
17. Performance Testing – Bench
18. Performance Testing – Animal
19. Performance Testing – Clinical

While some of it is boilerplate stuff, all of it requires attention to detail and effective document control throughout your product development lifecycle to create, maintain and then extract the correct information from your QMS to demonstrate compliance.

See how Cognidox can help you be ready for FDA compliance

What can go wrong with a pre-market notification?

There are several common mistakes that lead to 510(k) rejections.

It’s crucial that your submission clearly demonstrates your device’s safety and effectiveness, with robust validation testing and risk management data. Ensuring all forms are filled out and submitted correctly is vital.

75% of 510(k)s are rejected at the first submission to the FDA

Preparing all this documentation is a huge task. If you’re not organised it’s easy to omit vital information. Many fall at the first hurdle by not having the right files in the right format. Others do not make the right case for ‘substantial equivalence’. Still others fail to submit the required evidence of their design controls and validation processes that can prove their device was designed and built-in line with FDA quality regulations.  

Reasons for rejection include:

• Substantial equivalence not proved
• Inadequate documentation (missing elements from the FDA 510(k) Submission Checklist)
• Submission incorrectly formatted
• Inadequate testing data
• Absent Risk Management data
• Inaccurate Device Descriptions
• Discrepancies in indications of use
• No records of validation testing

It’s crucial that your submission clearly demonstrates your device’s safety and effectiveness, with robust validation testing and risk management data. Ensuring all forms are filled out and submitted correctly is vital.

Tips for Getting Your 510(k) Submission Right the First Time

It’s a tall order, but here are 6 tips to help you get your approach to 510 (k) right:

1. Follow the checklist: the FDA provide a clear list of everything that must be included

2. Format it correctly: read the guidelines properly, so you’re not rejected on a technicality

3. Use a consultant: Shaun Knights at Callaly is one medical device developer whose recent product releases all received 510 (k) clearance at their first attempt. He says much of their success is down to using a third-party expert to interpret the regulation and structure the submission. There’s a list of some great medical device consultants right here who could help you navigate your way through.

4. Adequately prove substantial equivalence: There is quite a bit of FDA support online to manage this, but using a consultant will help you correctly structure your testing summaries and provide precisely the evidence the FDA needs to give clearance. Some of your submission will be made public, so knowing what you must include in these sections and what could be shown elsewhere will prevent you from giving IP away unnecessarily.

5. Use document and design control tools from the beginning: 510 (k) requires you to demonstrate in your device description exactly how you have managed risk, imposed design controls and captured non-conformances as you have built your product. There is a lot of detail you will need to pull out of your quality management system to evidence your compliance. If you have structured, recorded, automated and indexed your design and development processes within an eDMS, then locating the documentation for inclusion in the 510(k) will be much less stressful and time-consuming.

6. The FDA will likely come back with questions, but that’s OK. Just factor in extra time to your launch plans to ensure you’re not caught out.

What Happens After 510(k) Clearance?

After your submission is accepted, the FDA will post your clearance on their website. Unlike other regulatory processes, the FDA does not issue a formal certificate for 510(k) clearance. Instead, the official approval is the clearance letter they send you, which will be published online for public access.

Conclusion: Securing FDA 510(k) Clearance

Getting your 510(k) submission right the first time can save you time and money, but it requires careful preparation and attention to detail. Common mistakes—such as missing documentation, inadequate testing data, or improper formatting—are the main reasons for rejection. With the right tools, processes, and expert support, you can significantly increase your chances of a successful submission. Don’t leave it to chance—ensure you meet all FDA requirements, and consider using a document management system to keep everything organised.