
Introducing Startup FDA: Demistifying FDA submissions through Open Source - kirillzubovsky
http://themacro.com/articles/2016/05/fda-advice-for-startups/
======
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.

~~~
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
Hello! I'm CTO of Shift Labs. Happy to answer anyone's questions about making
the FDA process more accessible to startups.

~~~
brandonb
This is super cool.

Someone I know is working on a platform to help startups with FDA compliance
(specifically the quality systems requirements), who I think would be
complementary to this effort. Mind emailing me at brandon@cardiogr.am if you'd
like to be put in touch?

~~~
seehafer
This would be me. @koji, I think this is fantastic, as my startup's mission is
precisely to demystify the process of getting (and maintaining) regulatory
clearance/approval. Would love to connect. Just reached out over email.

------
akehrer
First of all, thank you Shift Labs for putting up their information and
helping make confusing regulatory processes clearer.

Secondly, I want to let people know my company[1] works with many start-ups in
the medical device space that are developing regulated products, both 510(k)
and CE mark. We are engineers that understand the regulatory process not just
regulatory consultants.

If anyone is interested feel free to contact me akehrer@in2being.com.

[1] [http://www.in2being.com/](http://www.in2being.com/)

------
drinkherbs
My name is Ram and I'm interested in how to submit a beverage product to the
FDA, particularly when the beverage contains a dietary supplement. According
to the FDA guidelines from 2015, dietary supplements should not be presented
as food. But of course, many are, eg DrinkNeuro.com. Any assistance on how to
effectively work with the FDA on this would be very helpful. Please email
Boschpower@gmail.com

~~~
koji
We don't have any experience with food and supplements with the FDA, so don't
have a lot to offer. The hope is that based on your experiences, you could
contribute to github.com/Shift-Labs/StartupFDA as you learn the process.

------
bkolko
This is beth, also of Shift Labs. I've been offline in Haiti for the past
several days, but am happy to answer questions as well. Thanks to all for the
support for the repo -- we're excited to expand the content.

------
alexvino
Hi. Im interesting to help for my [http://heartin.net](http://heartin.net) I
done 501k and general documents but still need help - email me
alex@heartin.net

~~~
koji
Alex, happy to help. First thing would be to review our 510k documents we made
available on the github repo, and see if there are any specific gaps. Start a
conversation and submit an error request so we can start expanding on what's
there!

