I’m currently drafting a 510(k) submission at the company I work for that details a significant material change on our already marketed devices. This submission is targeting FDA experts in the field of neurovascular and peripheral vascular guidewires and catheters. Because my audience are experts and ultimately decide if the material change can be marketed, my choice in language is incredibly important. It is not uncommon to spend 30-40 minutes in a meeting debating over the phrasing of a single sentence out of concern for how the FDA may interpret that sentence.

This submission requires me to research and understand FDA guidelines as well as international standards applicable to my company’s devices. There is not a guide that clearly lays out all the standards and guidelines you must comply with. To ensure I am complying with the right standards, I had to search through FDA guidance’s, previous device submissions, and EU regulations to determine what does and does not apply to our devices. This research alone took over a week and required me to meet with multiple department heads to understand why or why not a guidance, standard, or regulation applied to us.

This submission requires me to collaborate with R&D engineering, quality engineers, and operations experts. It is reviewed by 8-10 internal reviewers where I receive constant feedback and must make many revisions. Because of major collaborative effort, I had to get creative with how we collaborate. The FDA has a very specific way they require you to provide this submission by way of a complex and poor performing PDF template. The PDF cannot be updated by multiple people at the same time so I had to find a way we could work together. As such, I created a SharePoint where I would transcribe the FDA’s requirements from their template into word documents that my team and I could work on together. Each section was broken up into their own folders and requirements to easily be transcribed into the template upon section completion. This part of the project allowed me to put on a Project Management role as well as a Technical Communicator role, making tasks and assignments flow smoothly.

This document is the most scrutinized and professional document I have worked on in both an academic and professional environment. This is the first time I’ve ever been involved in writing a 510(k) and it has been stressful, but worth it. This submission has taught me a lot. Not only that I get stress-induced eczema, but also research, collaboration, and the importance of organization. It has also given me the biggest opportunity to implement my academic experience into professional experience.