An FDA "curriculum" helps guide medical device startups through regulatory maze

It’s tough for medical device companies to get that stamp of FDA approval, but the labyrinthine regulatory pathway certainly doesn’t help things. Regulators want to change that:

“…we learned that the delivery of new therapies to patients can be accelerated if medical device innovators — including entrepreneurs and university students and faculty — understand FDA’s regulatory processes,” FDA researcher Francis Kalush wrote recently.

She blogged about the administration’s “National Medical Device Curriculum” – a free regulatory training program geared largely toward “small companies that may not have the expertise to navigate FDA’s requirements.”

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It’s made up of a number of fictional case studies that are tailored to help academic institutions, startups and other tech innovators to make sense of the bureaucratic approval process.

The governmental powers-that-be cobbled together said curriculum “in scores of meetings” over the past four years, collaborating with a number of top universities including Stanford, UVA, Howard, Johns Hopkins and UPenn. It has been tested at some of those sites as well.

It really has some nice, basic-to-the-bone information, such as this regulatory device overview that I’d recommend bookmarking for anyone who hates paperwork and arbitrary acronyms. The “university-level” program contains a number of videos on topics like premarket notification, bioresearch monitoring and investigational device exemption. (They’re pretty dorky, but helpful – the FDA likes elevator music and an early ’90s color palette, but the content is spot-on.)

So, there you have it. Educate yourself.