Regulatory Information: Anatomical Models used in Preoperative Planning
Formlabs is an industry-leading manufacturer of 3D printers and materials used by healthcare providers to support the practice of medicine. Bold blue text below indicates a link to a third party webpage with supporting information. Questions? Email [email protected]
3D printed anatomical models that are marketed for diagnostic use may be considered medical devices and may be subject to regulation. As of this writing, the latest FDA Current Practices and Regulations document can be found here. We recommend that point-of-care manufacturers become familiar with the entire document, particularly slide 16.
In 2018, Formlabs Form 2 was the first and only stereolithography 3D printer to be validated by Materialise as part of the the first FDA-cleared process to create accurate patient-specific anatomical models for diagnostic use. Since that time, Formlabs continues to offer the most affordable 3D printers that have been validated in 510(k)s for the production of diagnostic use anatomical models across multiple specialties. As of November 2021, the list of FDA-cleared processes includes:
- Materialise Medical: Form 3B and Form 3BL have been validated by Materialise as part of its FDA 510(k) cleared process using Mimics software.
- Synopsys: Form 3B and Form 3BL have been validated by Synopsys as part of its FDA 510(k) cleared process using Simpleware software.
Formlabs also announced a collaboration with GE Healthcare to support radiologists who use GE Healthcare’s Advantage Workstation to prepare 3D CT or MRI data to assist in diagnosis and procedure planning, then export using 3D Suite in a form that is ready for 3D printing on Formlabs systems. Formlabs is also proud to partner with segmentation providers including Axial3D and Medviso (CE-marked).
While a growing number of open-source and commercial segmentation software is available, in some cases and countries models marketed for diagnostic use should be prepared using segmentation software cleared by the FDA. Please consider local regulations, material data sheets, software capabilities, sterilization requirements, and institutional requirements before 3D printing or using anatomical models.
Preoperative planning models for diagnostic use are considered Class I medical devices (Medical Device Directive, 93/42/EEC). Our partner, axial3d, often prints these devices with Formlabs technology and has registered these devices with the MHRA. Please review the list of all other registered devices.
For additional perspective, you are welcome to read this interview with the Group Manager for the Devices Regulatory Group at the Medicines and Healthcare products Regulatory Agency (MHRA; London, UK). Based on recommendations from the MHRA in October 2019, we encourage those in the UK with more detailed questions to contact the MHRA Innovation Office.