By Eric Bubar
Exactly what is an e-NABLE device, and what do regulators, like the FDA, think of them? These are great questions, and over the four years I’ve been volunteering with e-NABLE, there have been numerous discussions on this topic. Every so often, the same questions arise: Do we need to be concerned about FDA oversight? As a crowd-sourced movement of volunteers (often) with no medical training, what should (and shouldn’t!) we claim about our devices?
First and foremost, the fact is that the FDA considers most e-NABLE devices as “Class 1 Exempt” devices. Answers beyond this simple fact are much less clear, but various founding members of e-NABLE regularly communicate with the FDA. The FDA is not interested in hampering the innovation our work can offer, as long as we are providing devices at no charge and not making glorious claims of their medical prowess (or our own!).
The recent release of FDA guidance on 3D printing, while informational, is targeted towards larger-scale commercial manufacturers and not the volunteer type of work we do. If you’re ever wondering if your e-NABLE work crosses a line over being Class 1 Exempt, you’re encouraged to reach out to the FDA (DICE@fda.hhs.gov).
The obvious follow up question of whether you can get into legal trouble for making these devices is beyond the scope of this article. To briefly address this, e-NABLE does provide guidance on this matter. Also of note is that to date, as far as I am aware, there have been no legal ramifications for any of the thousands of e-NABLE device providers.
[Note: None of the information provided here is legal advice. I am not a lawyer and everything written here represents my own observations as an e-NABLE volunteer.]