Katie Weimer’s presentation on, “3D Printed Medical Devices: What’s Next?”, at the 10x Medical Device Conference was amazing. Some great examples of how the technology is being used to form ‘patient-specific’ replacement bone sections, and scope for the future with regards to surgeons at the hospital printing these parts in-house via installed machines potentially in or near to the operating theater.

Implants aren’t my area so I presume that such ‘patient-specific’ devices made from traditional materials (metallic prosthetics) are considered “custom medical devices” as they are not ‘marketed’ and so are exempt from the usual product FDA regulations (no 510(k) needed). If this is true I also presume that such devices are ‘high risk’ (could be considered class III) but are exempt from ‘general controls, special controls and premarket approval’.

Like I said, this isn’t my area but the above is really a precursor to my question: If hospitals did 3D print such devices in-house would they be considered the ‘manufacturer’? Also, as in the product FDA regulations exemption above for such custom devices, would hospitals also be exempt from FDA 21 CFR 820 (no FDA-based QSR or DMR) if they were 3D printing custom bone sections in-house? How would they be regulated?

Any thoughts are welcome.

source: https://www.linkedin.com/groups/78665/78665-6134012195786285058