Jordan Lipp, Esq. | Partner, Davis Graham & Stubbs
Today, the FDA issued new guidance for the industry on 3D printing of medical devices, entitled “Technical Considerations for Additive Manufactured Medical Devices.” Considering the recent advances in 3D printing technology, especially with anatomically-matched devices that are built for individual patients, FDA guidance on this issue is welcome. The guidance provides the FDA’s current thinking on the myriad of issues from material controls, process validation, and device testing, to cybersecurity.
This guidance also provides information on labeling considerations involving 3D printed medical devices. With regards to patient-matched device, the FDA recommends that additional labeling be provided with:
- patient identifier,
- use (e.g., left distal femoral surgical guide), and
- final design iteration or version used to produce the device.
Also, with regards to labeling, the FDA recommends both reviewing whether the expiration date is the same as the typical shelf life for a non-patient-matched device and including a precaution that the patient should be surveyed for potential anatomical changes prior to the procedure.
The newly issued guidance is just a stepping stone. As the FDA noted in its press release, “our recommendations are likely to evolve as the technology develops in unexpected ways.” And, of course, as this is a guidance document, so it is nonbinding.