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?
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.
Agreed. We'd like to expand fom just FDA specifically (and 510k specific), and get into maintaining quality standards. There are numerous different segments you can expand to as well.
It seems to me the big chunk of the problem is that my local hospital doesn't really have to compete with anyone and has rather free reign in setting prices.
> It seems to me the big chunk of the problem is that my local hospital doesn't really have to compete with anyone and has rather free reign in setting prices.
Yes, there is definitely lack of competition at the provider level which has gotten worse post-ACA. But in this context I'm talking about lack of competition among technology manufacturers. Really easy to set high prices for things when competitors can't enter your market without going through several hoops. That's how you get guys like Martin Shkreli.
There is also a very high overhead required for simply getting products to market. When the easiest way to proceed is by hiring high-priced consultants who hold all the keys, it makes it very difficult for new ideas to become available. Only established players really have the pockets deep enough to navigate the regulatory process.
There are numerous costs that you can't avoid, such as lab testing, clinical trials, and fees for acquiring certifications, but being able to do more on your own as far as documentation is a big first step.
Have you thought about including redacted copies of 510(k) submissions available from the CDRH FOIA Electronic Reading Room [1]? You could probably just provide a list of links to the PDFs.
Here's an example of one for a powered laser surgical instrument (warning: 57MB PDF):
We had downloaded several 510(k)s early in our process, but found them so heavily redacted that they didn't really give the overview we needed. That's why we worked so hard to redact as little as possible in our own docs. I'll dig deeper into that set of links to see if there are some that have more info in them. Thanks!
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!
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
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.
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.
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).
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.
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.
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.
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.
23 comments
[ 3.4 ms ] story [ 54.8 ms ] threadSomeone 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?
It seems to me the big chunk of the problem is that my local hospital doesn't really have to compete with anyone and has rather free reign in setting prices.
Yes, there is definitely lack of competition at the provider level which has gotten worse post-ACA. But in this context I'm talking about lack of competition among technology manufacturers. Really easy to set high prices for things when competitors can't enter your market without going through several hoops. That's how you get guys like Martin Shkreli.
There are numerous costs that you can't avoid, such as lab testing, clinical trials, and fees for acquiring certifications, but being able to do more on your own as far as documentation is a big first step.
Here's an example of one for a powered laser surgical instrument (warning: 57MB PDF):
http://www.fda.gov/downloads/AboutFDA/CentersOffices/Officeo...
[1] http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/read...
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.
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.
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).
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.
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.
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/