Startup FDA Resources

Startup FDA 510k examples

*Open Source Startup FDA is a repository on GitHub where medical device startups are encouraged to open source and share their 510(k) submissions with each other. The idea is to demystify the process and show how much variation there can be in a successful submission for FDA clearance. Shift has already uploaded its 510(k) files with sensitive information redacted here, and is encouraging other startups to do the same.

“When it comes to FDA clearance, people at startups don’t know how to start,” says Beth Kolko, the cofounder and CEO of medical device startup Shift Labs (YC W15). “We personally spent a year fretting about it. We were thinking, ‘Can someone please just give us a template for what our submission should look like? If you tell us what to do, we’ll do it.'”

According to Kolko, the confusion around the regulatory process is not only damaging to the psyche of startup founders: It actually holds back the entire industry, and the patients it is meant to serve. “I am convinced that this is a huge barrier for innovation in the medical device space,” Kolko says.

*This article was originally published on Y Combinator's blog, which is excellent.  We suggest subscribing to their blog and applying for the next YC batch. Even if it's not a great fit for you, the application process is a useful exercise in thinking about how to grow your startup.