First, you conceptualize your idea for a new medical device. You determine what medical issue it is going to resolve and how it will be leveraged by doctors and patients. You research the current state of the market to understand the level of need and how to best position it amongst the devices already out there. You spend time designing your device and ensuring it is easy to use. Finally, you are ready build your 510(k) application in order to submit your device for FDA review.

While it may feel like the hard work is over, in reality, it is just beginning. Obtaining FDA clearance for your device involves submitting a 510(k) application. This application is normally over 1,100 pages and requires a plethora of information, files, documentation, and reports. The sheer size and scope of this application will leave you open to all types of errors and mistakes. The result is that the hours you have spent putting together this crucial document are wasted as your application is rejected and you have to start over.

While it may feel like the hard work is over, in reality, it is just beginning. Obtaining FDA clearance for your device involves submitting a 510(k) application. This application is normally over 1,100 pages and requires a plethora of information, files, documentation, and reports. The sheer size and scope of this application will leave you open to all types of errors and mistakes. The result is that the hours you have spent putting together this crucial document are wasted as your application is rejected and you have to start over.

While the FDA will provide general guidance regarding what needs to be included in a 510(k) application, they provide little else in terms of document organization or project management. This often leaves submitters alone with a checklist, blank Microsoft word document, and the impossible task of wrangling hundreds of pages of information such as packaging labels, clinical trial reports, engineering specs, device details, sterilization, and shelf life data, and more.

In today’s conversation, we are going to discuss the top 5 reasons why you should not do it alone when submitting your 510(k) application.

#1 – You Need To Have The Most Up To Date FDA Documents

As you navigate through your 510(k) application, you will notice several places that require FDA documents. The FDA will supply these documents as they are necessary for submitting a complete application. However, documents and forms such as your Cover Sheet, Indication of Use, and Declaration of Conformity to a Recognized standard change often. It can be difficult to know if you are using the most up-to-date version. The last thing you want is to learn you are not compliant by having your application rejected.

These types of requirements can lead to errors among those who are doing this on their own. However, when you leverage the power or a 510(k) application builder program such as Essenvia’s, you no longer have to worry if you are using the right document. We automatically populate your application with the most up-to-date FDA templates. All you need to do is fill in the necessary information.

For example, the FDA requires a specific form for your device’s Indication of Use statement. This is a crucial document because it explains what you plan to use your device for after receiving clearance. This is also a document that the FDA tends to update regularly. Also, as anyone who has used the FDA website will tell you, these documents are not always the easiest to access. Our 510(k) builder always provides the most up-to-date form and automatically inserts it into your application.

#2 – Discrepancies and Errors Will Lead To Rejection

The reason automation has become so popular in today’s society is it cuts down on both time and errors. Brands no longer require their sales reps to manually type out their outreach emails because it is highly likely there will be a typo or incorrect statement. The pitfalls of manual data entry are just as evident when it comes to 510(k) applications.

The application will require you to repeat the same key information such as indications for us and device descriptions in several places. For example, your indication of use statement is a key point that the FDA will review. Even if you are clear on what that statement is, it’s possible it can be phrased in several different ways. If the reviewer feels this statement is inconsistent, they will reject your application. In our application builder, we ensure this type of content is consistent throughout your entire application. All you need to do is type it once and our Changelock™ function ensures your information cascades to all relevant sections throughout your application.

#3 – You Have A Lot Of People You Need To Communicate With

They say if you want something done right, do it yourself. Regardless if you agree, one undeniably true fact is that you cannot compile the data and information you need for a 510(k) by yourself. As the project lead, you are required to communicate with several people both inside and outside your organization. This requires countless emails, dropbox folders, JIRA tickets, and anything else that delivers the content you require.

Ongoing communication amongst this many parties is ripe for confusion and errors. This is due in large part to your teammates not being well versed in regulatory terminology. They are also not nearly as knowledgeable as you are about the various requirements set by the FDA. Therefore, it is your responsibility to translate their work into content that follows the proper terminology and requirements.

A system must be put in place on day one. A process that allows you to get a handle on the various documents that are floating in your direction. You will benefit greatly from a program that helps collect this information and store it in an organized manner. This will relieve your stress and allow you to confidently move forward knowing you have the most up-to-date and accurate versions of everything you need.

#4 – The Fear and Anxiousness Of Getting It Wrong

Gaining FDA approval is a daunting and pressure-packed task. This is the major hurdle stopping your device from hitting the market and turning a profit for your organization. Key stakeholders including executives, shareholders, investors, and team members are looking for you to deliver. Messing up could mean a loss in revenue, decreased profits, and possibly even losing key investments. That scenario is enough to paralyze anyone with fear and anxiety.

While you cannot minimize the importance of a 510(k) application or decrease its size, you can determine the best way to approach it. This includes setting up a process that safeguards against errors, discrepancies, and the use of outdated documents. When you leverage the power of our app builder, you no longer fear making a crucial mistake such as using the wrong template or forgetting to update a section of your application. Your anxiety will significantly lessen knowing you took the necessary steps to produce an error-free and rejection-proof application.

#5 – Your Time Is Better Spent Elsewhere

The truth of the matter is your time is precious and better served working on other things. While putting together this submission may be your top priority, that does mean you have time to waste hunting down the latest FDA documents and ensuring the information people are sending you is up to date. Furthermore, it should not be your responsibility to then take these thousands of pages and attempt to use Microsoft Word to comply with the FDA’s mandated e-copy format.

On the topic of time-consuming tasks, it is worth talking about the RTA checklist that is required at the end of each submission. This is a time-consuming document that appears after you just spent countless hours compiling and formatting your entire application. Our software will automatically tell you which parts of this checklist apply to your device. Then, it provides a convenient function that allows you to answer the questions as you complete the section instead of at the end of the process.

While we can’t perform most of the leg work for you, we can make it easier to compile and organize what you do collect. We also make sure you are not wasting your time worrying whether or not what you are submitting will be rejected by the FDA. The time we save you can be better spent tending to your other tasks and responsibilities.

Conclusion

Submitting a 510(k) application is a complex process that requires the help of an experienced expert. The sheer size of this project leaves most people open to errors and mistakes that result in being rejected. Our program has identified these common areas of mistake and provides solutions to ensure that they do not happen to you. Together, we can submit a 510(k) application that you can feel confident will be approved by the FDA.

About Essenvia

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 program 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 510(k) submission.