The US regulatory framework for 3D-printed anatomical models explained

On 31st August, the US FDA presented its opinion on 3D-printed anatomical models during a joint meeting with the Radiological Society of North America 3D printing Special Interest Group (RSNA SIG).

3D-printed, patient-specific anatomical models are used by physicians to visualize or measure patient-specific anatomy in order to help them make a diagnosis, or manage patients’ health or treatment. Such uses are considered diagnostic and the models therefore fall under the medical devices regulation.

FDA opinion is to regulate the software used to print the models, rather than the models or the printers themselves. The software would be considered a class II medical device, regulated under the product code LLZ, for picture archiving and communications systems.

Software would need to get 510(k) clearance before being used. The submission should include validation data that address accuracy and reproducibility. Particularly, performance testing should include clinically relevant data for the specific anatomy type and phantom testing to ensure radiological images are correctly reproduced in the printed model.

Details on the recommended 3D printer model, material and post-processing steps should also be included in the submission, along with data supporting printer compatibility. FDA staff recommend companies to use the draft guidance Technical Considerations for Additive Manufactured Devices for advice, even though it is not specifically intended for 3D printing software.

As to which companies need to get a clearance for their software, this will depend on the intended use of the software:

  • A 3D printer manufacturer or a software company would need to get clearance for their software if they are marketed with the claim for creating 3D anatomical models for diagnostic use.
  • A clearance would not be required if the software or printer is marketed for general use.
  • Clinics or other facilities that market the models would not need to get clearance if they are using an already cleared software.
  • If clinics are only using the models internally, no clearance would be needed either.

For those who are interested, the agenda and webcast of the meeting is available on the FDA website by clicking here.