[cturitzin]

I've spent the last 6 months in FDA 510k world and as time goes on, I'm more and more convinced of the need for something like this.

The hardest part has been to clearly define what experiments we need to run on our product for the FDA to accept it. There is nothing inherently difficult about this, but the problem is the lack of available information and feedback cycles to get the information.

For example, the FDA has a feedback process called 'pre-submissions'. This is good, but the problem is the cycle to ask a question and get an answer is 3 months.

I'm happy that there is a growing group of entrepreneurs working within the regulatory system. Hoping to see more tools soon.

[koji]

Our 510k is definitely a sliver of the various forms of requirements that may be needed depending your product space and classification.

We're hoping this repo will grow as other contribute, and be a space where people can find references for various types of regulatory support.

If you'd like to contribute, we'd be happy to give you access.

[ibnroberttuta]

Have you used a consultancy based group to help with the documentation/app.?

Doing a 510k w.o that experience/perspective seems insane (especially for a startup(?)).

Also, I'm not sure which field you are in, but I've generally been able to access the applications from previous submissions in my field (Personal exoskeletons).

[cturitzin]

Yeah we've hired a consultant. The stuff that has been most frustrating is very domain specific.

For our product category (sleep apnea diagnosis) the FDA has an unwritten rule that all devices must run a clinical study compared to existing tools.

The hard part has been extracting the exact details that would make an acceptable study in their eyes (testing environments, statistical methods...)

Also it seems like the testing standards have evolved over time and this isn't documented either. Only way we've been able to learn the standards is by giving the FDA a proposal and getting feedback on it.

We've gotten a few FOIA'ed 510ks of similar devices. Unfortunately they are 90% redacted and not very helpful.

Looking back on it, it may have been worth it to seek out a person who had gone through this exact experience before. That could have saved some time/effort.

[koji]

We hired a consultant to help put together the paperwork and deal with the actual submission itself. They did not support us on putting our documentation together, and could not provide specific answers to questions we had.

What they did provide was a means to package our paperwork together in a way that is recognizable to FDA reviewers, and the resulting work is what you see in the StartupFDA repo.

We still had to produce all the work, and interpret the FDA guidelines on our own. It was a bit of a compromise on speed and cost, but worked for us.