Developers who want to release a medical device in the US need to seek permission from the FDA. Depending on the classification of your device, this can mean obtaining 510(k) clearance by submitting a package of documentation complete with a cover letter for the FDA to approve. But what can go wrong, and how can you get it right 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 510k submission?
You can make a 510 (k) submission if you’ve developed a medium risk, Class 2 device that you have proved is ‘substantially equivalent’ (SE) to another device on the market (known as a predicate).
If you can demonstrate through your documentation that your device has the same ‘intended use’ and maintains the same levels of safety and effectiveness as the predicate, then the FDA will permit you to market it in the US. Developers of high risk (novel and Class 3) devices, on the other hand, will need to seek Premarket Approval (PMA) from the FDA, which is a significantly more detailed and lengthy process. The PMA requires data from human clinical trials and much more in-depth scientific evidence to prove its safety and compliance.
The 510 (k) clearance route is less time consuming, expensive and generally less burdensome than going through the entire PMA process, which is why it is a method of regulation reserved for lower-risk devices.
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:
- Medical Device User Fee Cover Sheet (Form FDA 3601)
- Center for Devices and Radiological Health (CDRH) Premarket Review Submission Cover Sheet (Form FDA 3514)
- 510(k) Cover Letter
- Indications for Use Statement (Form FDA 3881)
- 510(k) Summary or 510(k) Statement
- Truthful and Accuracy Statement
- Financial Certification or Disclosure Statement
- Declarations of Conformity and Summary Reports
- Device Description
- Executive Summary/Predicate Comparison
- Substantial Equivalence Discussion
- Proposed Labelling
- Sterilisation and Shelf Life
- Electromagnetic Compatibility and Electrical Safety
- Performance Testing – Bench
- Performance Testing – Animal
- 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.
What can go wrong with a pre-market notification?
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
What can I do to ensure my 510(k) submission is right 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.
One last question, will I receive a registration certificate after 510(k) clearance?
Nope. The FDA will issue a 510(k) clearance letter and post it on their website. The website posting is your official proof that your device was cleared by the FDA.
Securing 510 (k) clearance is no walk in the park. But with the right support, attention to detail and level of document control you will be able to avoid the simple errors and significant omissions that can cost you unnecessary time and money on your way to market.