The 510(k) clearance process is often met with a mix of trepidation and anticipation by medical device companies, and medtech companies’ desire to bring products to market quickly can lead to a few common mistakes.
Inconsistency With Documentation
The intended use statement often is screwed up by inconsistent application into other sections of the 510(k). A number of sections throughout the application require you to repeat that intended use statement, and you’d better have it right if you want the FDA to accept your submission.
A common mistake is confusion between statements that are more about indicated use than intended use, so it’s important to differentiate the two.
Under the FDA’s “Refuse to Accept” (RTA) policy, the agency has 14 days to review your submission and ensure you’ve submitted everything they would expect, and that contents are what they expected. The agency also will do a quick review of intended use, and if it doesn’t pass muster, the application will be kicked back to you.
Not Using The Checklist
Use the guidance document the FDA provides for your 510(k) submission! The (RTA) checklist is available here, beginning on page 17. The FDA always states what it is going to do and what it is looking for, so nothing should be a surprise.
Follow the checklist exactly, then give your reviewer a heads-up by referring to the relevant pages of your documentation next to the checklist items. Providing this guidance with your 510(k) submission lets the FDA know exactly where pertinent information can be found and is a good indication that you’ve submitted everything needed.
Not Providing All Expected Testing
FDA used to accept “I promise” statements, where you as the submitter could promise to complete things — such as sterilization, validation, or biocompatibility — later. FDA no longer accepts those “I promise” statements, but I understand that many people mistakenly believe they still can use them.
Not providing the testing that FDA expects will delay your clearance. You might be able to “fake it” to get through the initial RFA phase, but a review of sections by FDA will discover these are incomplete. Remember, different types of testing (such as biocompatibility, electrical safety, and sterilization validation) can take 10 weeks or more, so your clearance can end up being put on hold.
Also worth noting is the trend of “more is more” when it comes to testing expectations from the FDA. Whereas previously you may have been able to leverage existing biocompatibility data in some cases, now the agency wants to see testing specific to your own product.
You should also be careful to include protocols, results, and reports, allowing FDA to verify the rigorousness of your testing.
Not Doing Real-Time Shelf Life Studies
FDA wants evidence to back up claims of stated shelf life. Many companies use an accelerated aging process, following an accepted methodology to determine shelf life. FDA usually accepts these as evidence, but in our experience, providing some real-time shelf life studies to corroborate the accelerated aging will help you out considerably.
Test out many data points, such as 1-, 2- and 3-year accelerated data, along with some real-time testing. If you plan these out well, there’s a good chance you will have 1-year shelf life samples for doing real-life aging tests. FDA wants to see a correlation between real-time and accelerated aging data. Help to close the gap for them by planning for it.
Underestimating Risk Management Requirements
Regulatory bodies want to see good documentation and risk management practices. Be prepared to show your list of requirements and provide the paper trail for your traceability. Your 510(k) submission is effectively a story from which you want the FDA to conclude that you have a safe product that is substantially equivalent to a predicate device.
Your design controls play a big role here as your documented, objective evidence proving the safety and efficacy of your product. The contents of your design history file (DHF) also can be used as a guide from which to prepare the 510(k) submission.
Not Demonstrating Equivalence With Predicates
Descriptions comparing your device to another can be tricky. You need your device to be depicted as novel and unique, but not so different that the FDA thinks your predicate used is not a good example.
We all think we have a “better mousetrap,” so you may need to paint a picture using multiple predicates. However, this also is challenging, because you need to demonstrate why all the differences don’t matter. It’s definitely a bit of an art, and one that can benefit from the experience of an outside consultant.
Formatting of the submission incorrectly
For example, leaving out page numbers or the e-copy. The size of the file matters, too, and you need to name the file according to conventions.
Your 510(k) clearance is something that should be considered from the start of your product design process. For example, keeping an up-to-date DHF can help you to simply lift parts directly onto your 510(k) submission, rather than trying to start afresh.
Avoid the common mistakes we’ve outlined here and allow some time to put together a well-written submission. If you’re in any doubt, seek the help of a consultant to help guide you through the submission process.
About The Author
Jon Speer is the founder and VP of QA/RA at greenlight.guru, Jon is a medical device industry veteran with over 18 years experiences having helped dozens of devices get to market over his career in a variety of roles including product development, project management, quality and regulatory. He is also a thought leader, speaker and regular contributor at numerous leading industry publications.