The Top 5 Reasons The FDA Rejects A 510(k) Submission
Sep 8, 2021
If you have ever put together a 510(k) submission, you know exactly how massive of an undertaking this project becomes. You spend hours and hours collecting data and documents from various departments. You then spend more time finding the right templates and trying to understand the FDA’s guidelines. Plus, you have to search for the most up-to-date templates to use. After all of this hard work, the last thing you want is to discover the FDA has rejected your application.
Unfortunately, this is what happens to over 64% of 510(k) applications submitted for FDA clearance. Over 30% of these applications are not even accepted for initial review. Having a worthy device and the content to back it up is not enough to achieve FDA clearance. In this post, we cover the 5 most common reasons a 510(k) gets flagged and to avoid it.
#1 – Using Incorrect Or Out of Date FDA Templates
There are several sections throughout your 510(k) submission that require you to use some type of FDA-issued form. These sections include your Medical Device User Fee Cover Sheet (From FDA 3601), CDRH Premarket Coversheet (Form 3514), Cover Letter, and Indications for Use (Form 3381). Each section requires you to use the latest FDA-approved template when submitting your application.
The FDA is regularly updating these templates which makes it increasingly difficult to keep yup. While using the wrong template may not result in an outright rejection, it does put your application at risk of leaving out key information. Essenvia’s 510k application builder will always supply you with the most up-to-date templates. This helps avoid wasting hours scouring the internet and hoping you found the right templates. Furthermore, you can submit your application in confidence and no longer worry about submitting an out-of-date template and missing key information.
#2 – Discrepancies In Information That Appears More Than Once
As we mentioned above, the quality of your device and the content you provide are only part of this complex process. The FDA is quite strict when it comes to consistency in the information you provide. For example, your Indication for Use Statement appears over 20 times in your application and the FDA requires it remains the same throughout. Even if the intent remains unchanged, your application will be flagged, paused, and possibly even rejected if the wording does not match up.
It may seem simple enough to pay extra special attention when repeating information throughout your application. However, what happens when something changes towards the end of your process? You are now forced to scan your entire document and manually make this change each time. With Essenvia, this tedious type of work is done for you. With our Changelock™ feature, once you make this change on one page, it cascades throughout your entire document. You no longer have to worry if you missed a section during your review.
#3 – Not Following The 510(k) Submission Refusal To Accept Checklist
As we mentioned earlier, over 30% of submissions are rejected before they are even reviewed by a real person. This is due to their failure to comply with the Refusal To Accept checklist. In simple terms, the RTA checklist is what the FDA uses to determine if your device meets the minimum threshold for review. This document proves that you are worthy of the FDA’s time and have a realistic shot of gaining clearance.
This checklist consists of 56 questions all about the content and information in each section of your application. If you want until the end to fill it out, you risk providing answers that are not consistent with what you provided earlier. It’s important to note that not every question applies to your device. Our application builder not only shows you which questions are applicable but allows you to answer them as you are putting your sections together.
#4 – Choosing The Incorrect Predicate Device For Your 510(k) Submission
As you may already be aware, the FDA requires all submissions to list a predicate device on their application. Essentially, it is your responsibility to select a device already on the market that is substantially equivalent to the device you are seeking approval for. This is one key way the FDA can determine if your device is safe and effective. You can review current devices and their information by searching the FDA’s medical device databases.
Your Indication of Use Statement must align with the predicate device you have chosen. Whatever you decide your device is going to do it must match up with what your predicate device already does. It is equally important that your device’s technological characteristics are similar to those of the predicate device you have chosen. To increase your chances of clearance, you can include a side-by-side comparison for the reviewer to examine.
#5 – Skipping Not Applicable Sections In Your 510(k) Submission
While a traditional 510(k) includes 20 sections, not every single one of them will apply to your device. This includes sections such as Class 3 Summary and Certification, Financial Certification or Disclosure Statement, Performance Testing (Bench and Clinical) Proposed Labeling, Biocompatibility, Sterilization, and Shelf Life, and Electromagnetic Compatibility and Electrical Safety. A common mistake made by first-time submitters is leaving these sections blank instead of using a standard not applicable statement.
Even if the section does not apply to you, you are still required to state that in writing. Our application builder software will auto-populate these sections with pre-approved statements. This allows you to move past these parts of the application and focus on those that are applicable and important.
As you can see, compiling the content and data is only half the battle. The FDA expects and requires you to follow various guidelines and procedures. These requirements are why investing in a support program like Essenvia will return a high ROI. Together, we can make sure you submit a rejection proof 510(k) application and that all of your hard work will be worth it.
Essenvia is an online software to streamline pre and post-market workflow for medical device companies by streamlining plans or activities to market, improving cross-functional collaboration, and automating steps to manage initial and subsequent device modifications.
Our tool is designed to help drastically reduce submission errors, streamline data and information gathering, save time, and help you submit a close to rejection proof as possible 510k submission.