Introducing Startup FDA: Demistifying FDA submissions through Open Source

Re:Introducing Startup FDA: Demistifying FDA submissions thr... by akehrer on Thursday May 19, 2016 @05:59PM (#11734207)

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...

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Re:Introducing Startup FDA: Demistifying FDA submissions thr... by bkolko on Sunday May 22, 2016 @11:40AM (#11748959)

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!

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