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I urge makers and more professionalized 3D printers to familiarize themselves with FDA guidelines[1] on 3D printing and internalize their thinking. No doubt th
by ENOTTY 7y ago
I urge makers and more professionalized 3D printers to familiarize themselves with FDA guidelines[1] on 3D printing and internalize their thinking. No doubt this will slow you down, but you have time right now to prepare before the shortages begin. This will make things safer for patients, give confidence to medical professionals that you have your head in the right place, and likely demonstrate good faith in the event that the FDA comes after you (after the COVID-19 crisis ends).
I recommend reading "Technical Considerations for Additive Manufactured Medical Devices". Then start discussions in your professional societies to make contact with the FDA as a group and start to develop guidance targeted for the COVID-19 emergency.
[1]: https://www.fda.gov/medical-devices/products-and-medical-procedures/3d-printing-medical-devices https://www.fda.gov/medical-devices/products-and-medical-pro...