Gain FDA Approval for Your Software
Developing software in an FDA-regulated environment provides an additional hurdle to overcome. At Pathfinder, we have experience with 510(k), class II and class III devices.
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FDA Software Development Guidelines
Make sure the mission is understood by all involved
- Having a clearly defined Minimum Viable Product (MVP) will act as a focal point for all members on the team.
- Ask as many questions as possible up front and ensure that all parties know what is being built.
Establish roles and responsibilities
- Knowing what you are responsible for will affect the planning and task management of each person on your team.
- Don’t assume shared responsibilities unless both parties agree on how to collaborate.
Plan a process and document every step
- Find the path that you think will work to get you to the goal and take note of each step, detour, and redirection.
- Shipping software for FDA approval requires multiple forms and documents to be created; from the development plan to the testing plan, from the code architecture document to the design layout guides, it all has to be completed before you submit.
- Every font, button, color choice, comment, spec, rejection, and approval all need to be documented.
- If the team needs to make changes along the way to help the project move along, it is ok- that’s part of the process. Just make sure you state what the reasoning was for the change, when it was made, and the new method that will be done that all parties agree upon.
- Don’t cut corners by omitting changes from you documentation; this will stall FDA approval.
- Plan for exponential amounts of testing as you continue to develop the software
- Be proactive in finding bugs when you plan the project
Double check all of the steps before submitting
There are three approaches to FDA regulated software development:
- You can do it right the first time (you’re a wizard)
- You can do it wrong and then document the mistakes and how you made them right (you’re human)
- You can do it wrong and try to cut corners (don’t do this; attempting to shave off a few things here and there will leave you in bad shape when you get audited by the FDA- yes, you will get audited)
FDA software approval is attainable, it just requires attention to detail and thorough, transparent documentation. When you’re developing an FDA regulated product, keep these guidelines in mind at all times and you can keep the process from becoming a nightmare.
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