[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 [e-mail] 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.

[koolba]

Neat idea. I think a general trend toward "Demystifying and streamlining government agencies" would do well for the business community.

[seehafer]

This is particularly important in healthcare, as this type of barrier to entry is a key contributor to rising healthcare costs.

[akehrer]

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):

http://www.fda.gov/downloads/AboutFDA/CentersOffices/Officeo...

[1] http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/read...

[bkolko]

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!