The process of submitting a medical device product for FDA 510k approval—with required documentation—is itself its own kind of project. It involves proper processes and procedures, documenting decisions and steps throughout the development process, and completing multiple iterations of testing to ensure quality.

So, how do you get started? How do you prevent the 510k process from becoming overwhelming? How do you ensure that you are taking the right steps during the development process and in your documentation preparation?

First of all, respect the process

Above all, the FDA 510k process must be respected and taken seriously. Taking a lackadaisical approach or considering documentation as an afterthought will only create headaches when it comes time for preparation of the submission to the FDA. So what does this mean in practice? 

Establish the right systems & procedures

First of all, part of the development process as outlined by the FDA includes utilizing quality management systems and following standard operating procedures. Taking the time upfront to ensure these systems and procedures are well-defined and in place is crucial—these are critical pieces of the puzzle. Your project team and development practices should abide by these procedures throughout the development process.

Trust us, this is not an area where you want to skimp, even to save time. Failing to follow the required procedures can result in lots of rework once development is complete or, worse, result in a failed / rejected submission. Working with a development team and organization that is familiar with these systems and procedures saves significant time in the planning portion of the project—that way your team only needs to be sure they follow the procedures versus creating them from scratch before the project begins.

Work documentation into your timeline

Second, make sure to develop a project plan that includes both product development time and 510k documentation time. This means allocating team members, time, and budget for the documentation and preparing the submission. Documentation for an FDA 510k submission should not be rushed or thrown together at the last minute—you’ll find that many of the documents are dependent upon one another. Creating a project plan that details the dependencies between the product development and documentation will help ensure items are completed sequentially and allow you to accurately plan for that documentation time.

This becomes particularly important during the testing iterations, as each phase of testing and subsequent documentation feeds into the next one. (Refer to our prior blog post for details on how to ensure quality during the testing phase of 510k submissions). Planning ahead, ensuring all dependencies are mapped, and allocating resources, will ensure the development and documentation efforts run smoothly in parallel.

Consult with a team that’s been through it

Lastly, engage with experts before you start the project. You don’t have to go into this blind. Leverage the expertise of organizations and teams who have successfully navigated the 510k process. It’s important to go in with a deep understanding of Federal Guidelines and regulations.
While it may seem simpler to refer to various online guides, teams familiar with the process can anticipate questions the FDA will ask about the submission and help ensure the documentation is properly worded. That’s right, even incorrect word choices during a 510k submission can result in multiple rounds of questions and responses back and forth with the FDA…and each and every response must still follow the same guidelines and processes. Needless to say, this can be extremely time consuming and resource intensive.

Understanding what the FDA is looking for upfront helps avoid this terrible churn. There are several tools on the market that make claims of being able to guide you through the FDA 510k process, but a tool can’t replace the tribal knowledge of an experienced professional. Only an expert can tell you what pitfalls to avoid when selecting your documentation tools, when creating folder structures for documentation, and even what to look for when navigating the FDAs site for submission.

So while the FDA 510k submission process can be overwhelming, it can be navigated seamlessly with the right insights. Proper planning and preparation before the project helps to ensure that all processes and procedures are in place and that resources are accounted for appropriately. Understanding all of the Federal guidelines and regulations is complicated, but engaging with experienced professionals is the best way to ensure you understand how to navigate the process. Ultimately, taking these steps will help get your project to the finish line faster and ensure a successful FDA 510k submission.

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